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Tests Waived by FDA from January 2000 to Present

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Tests can be categorized as "waived" from regulatory oversite if they meet certain requirements established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law. By selecting a test system name, you can view the CLIA data for that test system, including the corresponding 510(K) record, if applicable. The information is sorted first by the date of categorization of the test, then by test system name. This list does not include test systems that were characterized by the CDC prior to January 2000.

Document Test System Name
Analyte		 Analyte Specialty Effective Date
Fora Care Inc. FORA TD-4251 Blood Glucose Monitoring System  
K082482 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/03/2009
Fora Care Inc. U-Right TD-4252A Blood Glucose Monitoring System  
K082482 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/03/2009
Fora Care Inc. U-Right TD-4252B Blood Glucose Monitoring System  
K082482 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/03/2009
Fora Care Inc. U-Right TD-4254 Blood Glucose Monitoring System  
K082482 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/03/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
AgaMatrix WaveSense AMP Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/02/2009
Roche Diagnostics Accutrend Plus System  (fingerstick whole blood)
K051376 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/29/2009
Roche Diagnostics Accutrend Plus System  (fingerstick whole blood)
K051376 Cholesterol General Chemistry 01/29/2009
EPS Bio Technology Corp. EasyPlus mini R2N Self-Monitoring Blood Glucose Test System  
K081796 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/27/2009
EPS Bio Technology EasyMax N Self Monitoring Blood Glucose Test System  
K083099 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/27/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Rapid Response hCG Pregnancy Urine Cassette and Dipstick Tests  
K070921 Urine hCG By Visual Color Comparison Tests Endocrinology 01/26/2009
IM Diagnostics, Inc. IM Confirms II hCG Pregnancy Urine Cassette and Dipstick Tests  
K070921 Urine hCG By Visual Color Comparison Tests Endocrinology 01/26/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K032563 hCG, Urine Endocrinology 01/26/2009
Card Guard Scientific Survival, Ltd. PMP4 Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitoring System  
K082521 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2009
Cliawaived, Inc. CLIAWAIVED H. PYLORI WHOLE BLOOD RAPID TEST  
K024360 Helicobacter Pylori Antibodies General Immunology 01/22/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Conception Technologies hCG One Step Pregnancy Test Device (urine)  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 01/22/2009
Infopia USA Envision Autocode Blood Glucose Monitoring System  
K082020 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/15/2009
Fora Care Inc. FORA TD-4245 Blood Glucose Monitoring System  
K083664 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/12/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 01/09/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 01/09/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/09/2009
Entra Health Systems, Ltd., MyGlucoHealth Glucose Monitoring System  
K081703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/09/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Amphetamines Toxicology / TDM 01/07/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Phencyclidine (PCP) Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Cocaine Metabolites Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Methadone Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Methamphetamines Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Benzodiazepines Toxicology / TDM 01/07/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Barbiturates Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Morphine Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Tricyclic Antidepressants Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Oxycodone Toxicology / TDM 01/07/2009
Avnetir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Cannabinoids (THC) Toxicology / TDM 01/07/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Amphetamines Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Cannabinoids (THC) Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Phencyclidine (PCP) Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Cocaine Metabolites Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Methadone Toxicology / TDM 01/07/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Methamphetamines Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Benzodiazepines Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Barbiturates Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Morphine Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Tricyclic Antidepressants Toxicology / TDM 01/07/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Oxycodone Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Amphetamines Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Cannabinoids (THC) Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Phencyclidine (PCP) Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Cocaine Metabolites Toxicology / TDM 01/07/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Methadone Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Methamphetamines Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Benzodiazepines Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Barbiturates Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Morphine Toxicology / TDM 01/07/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Tricyclic Antidepressants Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Oxycodone Toxicology / TDM 01/07/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Amphetamines Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Cannabinoids (THC) Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Phencyclidine (PCP) Toxicology / TDM 01/05/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Cocaine Metabolites Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Opiates Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Methadone Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Methamphetamines Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Benzodiazepines Toxicology / TDM 01/05/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Barbiturates Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Tricyclic Antidepressants Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Oxycodone Toxicology / TDM 01/05/2009
BTNX Inc. Rapid Response hCG Pregnancy Serum/Urine Test Cassette and Dipstick Tests  
K071030 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response hCG Pregnancy Test 2000 mIU/mL  
K052694 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
CLIAwaived Inc. Pregnancy Urine Test (Dip-strip)  
K984079 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
CLIAwaived, Inc. Pregnancy Urine Test (Cassette)  
K984076 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Ketone Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Bilirubin Urinalysis 01/05/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Blood Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Glucose Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Leukocytes Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Nitrite Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick pH Urinalysis 01/05/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Protein Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/05/2009
Fora Care Inc. FORA D15c Blood Glucose Plus Pressure Monitoring System  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/05/2009
Fora Care Inc. FORA TD-4244 Blood Glucose Monitoring System  
K081715 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/05/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Blood Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 01/05/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick pH Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Protein Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/05/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Ketone Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Bilirubin Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Blood Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Glucose Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Leukocytes Urinalysis 01/05/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Nitrite Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick pH Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Protein Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/05/2009
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ReliOn micro Blood Glucose Monitoring System  
K082417 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/05/2009
SCI International Inc. New Choice Pro hCG Pregnancy Test Cassette Format  
K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
SCI International Inc. New Choice Pro Pregnancy Test Strip Format  
K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
Tyson Bioresearch, Inc., Diachex+ Evolve Blood Glucose Monitoring System  
K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/18/2008
Fora Care Inc. FORA D15b Blood Glucose Plus Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Fora Care Inc. FORA D15z Blood Glucose Plus Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2008
SCI International Inc. New Choice Pro hCG Pregnancy Test 2000 mIU/mL Cassette Format  
K052694 Urine hCG By Visual Color Comparison Tests Endocrinology 12/17/2008
Abbott ReliOn Ultima Advance Blood Glucose Monitoring System  
K081975 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/08/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Albumin General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Glucose General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 potassium General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Creatinine General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K950164 Calcium, Total General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K022312 Phosphorus General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K010670 chloride General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K010670 chloride General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K992140 potassium General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K992140 Creatine Kinase (CK) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K993211 Sodium General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K993211 Sodium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K993211 Sodium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K993211 Sodium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K992140 Creatine Kinase (CK) General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K992140 potassium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K010670 chloride General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K010670 chloride General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K022312 Phosphorus General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K950164 Calcium, Total General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 potassium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Albumin General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Jant Pharmacal Accutest Dual Sample Immunological Fecal Occult Blood (iFOB) Test  
K073431 Fecal Occult Blood General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest Immunological Fecal Occult Blood Test (iFOBT)  
K063693 Fecal Occult Blood General Chemistry 12/04/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck Blood Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Abbott i-STAT 6+ Cartridge  (Venous whole blood)
K053110 Hemoglobin Hematology 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous whole blood)
K053110 Glucose General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous whole blood)
K053110 Sodium General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous whole blood)
K053110 potassium General Chemistry 11/13/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott i-STAT 6+ Cartridge  (Venous whole blood)
K053110 Urea (BUN) General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous whole blood)
K053110 chloride General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT Crea Cartridge  (Venous whole blood)
K053110 Creatinine General Chemistry 11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous whole blood)
K053110 Hemoglobin Hematology 11/13/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott i-STAT E3+ Cartridge  (Venous whole blood)
K053110 Sodium General Chemistry 11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous whole blood)
K053110 potassium General Chemistry 11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous whole blood)
K053110 Hemoglobin Hematology 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous whole blood)
K053110 Glucose General Chemistry 11/13/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott i-STAT EC4+ Cartridge  (Venous whole blood)
K053110 Sodium General Chemistry 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous whole blood)
K053110 potassium General Chemistry 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT G Cartridge  (Venous whole blood)
K053110 Glucose General Chemistry 11/13/2008
Fora Care Inc. FORA D-10 Blood Glucose plus Blood Pressure Monitoring System  
K081714 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Nova Biomedical Nova Gold Blood Glucose Monitoring System  
K070255 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2008
Siemens DCA 2000 analyzer  
K951361 Glycated Hemoglobin, Total General Chemistry 11/13/2008
Siemens DCA 2000+ analyzer  
K951361 Glycated Hemoglobin, Total General Chemistry 11/13/2008
Common Sense Ltd. Norma-Sense Vaginal Discharge pH Test  
X070057 pH, Urine General Chemistry 11/04/2008
IM Diagnostics, Inc. IM Maxie 2 hCG Pregnancy Urine Cassette and Dipstick Tests  
K070921 Urine hCG By Visual Color Comparison Tests Endocrinology 11/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Mossman Associates, Inc. NicCheck I Test Strips  
K963733 Nicotine And/Or Metabolites Toxicology / TDM 11/04/2008
Wako APOLOWAKO Analyzer {Whole blood} 
K080123 Glucose General Chemistry 10/31/2008
Wako APOLOWAKO Analyzer {Whole blood} 
K080123 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 10/31/2008
Wako APOLOWAKO Analyzer  (Whole blood)
K080125 Triglyceride General Chemistry 10/31/2008
Wako APOLOWAKO Analyzer  (Whole blood)
K080125 Cholesterol General Chemistry 10/31/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IM Diagnostics, Inc. IM Confirms II plus hCG Pregnancy Serum/Urine Cassette and Dipstick Tests  
K071030 Urine hCG By Visual Color Comparison Tests Endocrinology 10/28/2008
Arkray USA, Inc. GLUCOCARD 01-mini Blood Glucose Monitoring System  
K082417 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
i-SENS, Inc. CareSens II Blood Glucose Monitoring System  
K080923 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
i-SENS, Inc. CareSens POP Blood Glucose Monitoring System  
K080923 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
LifeScan OneTouch Vita Blood Glucose Monitoring System  
K082513 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System  
K080960 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/17/2008
Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System  
K080960 Ketone, Blood General Chemistry 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Blood Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick pH Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Protein Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 10/17/2008
Arkray USA, Inc. Assure 4 Blood Glucose Monitoring System  
K070088 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Ketone Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Bilirubin Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Blood Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Glucose Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Leukocytes Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Nitrite Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick pH Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Protein Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Ketone Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Bilirubin Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Blood Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Glucose Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Leukocytes Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Nitrite Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick pH Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Protein Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/17/2008
Vertex Diagnostics UltraTRAK PRO Blood Glucose Monitoring System  
K082618 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM100  
K081451 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/25/2008
QUIDEL QUICKVUE DIPSTICK STREP A  (DIRECT THROAT SWAB)
K011097 Streptococcus, Group A Bacteriology 09/25/2008
Quidel QuickVue In-Line Strep A  (direct from throat swab)
K934484 Streptococcus, Group A Bacteriology 09/25/2008
Quidel QuickVue Influenza A+B Test  
K053146 Influenza A/B Virology 09/25/2008
Quidel QuickVue Influenza Test  
K991633 Influenza A/B Virology 09/25/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Quidel QuickVue RSV Test  
K061008 Respiratory Syncytial Virus Virology 09/25/2008
Quidel QuickVue RSV Test  
K070747 Respiratory Syncytial Virus Virology 09/25/2008
Common Sense Ltd. VA-SENSE Kit  
X070058 Vaginal pH General Chemistry 09/18/2008
EPS Bio Technology EasyPlus mini EasyMax self monitoring blood glucose system  
K082121 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Fora Comfort 2 in 1 TD-3250C Blood Glucose and Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Fora Comfort 2 in 1 TD-3260 Blood Glucose Plus Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Ketone Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Bilirubin Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Blood Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Glucose Urinalysis 09/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Leukocytes Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Nitrite Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick pH Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Protein Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/18/2008
PSS World Medical QUINTET Blood Glucose Monitoring System  
K072054 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Taidoc Clever Chek TD-3250C Blood Glucose and Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Taidoc Clever Chek TD-3250D Blood Glucose and Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM110  
K081450 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/12/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Andon Health Co., Ltd., andon AG-605 Blood Glucose Monitoring System  
K073030 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/04/2008
Andon Health Co., Ltd., andon AG-606 Blood Glucose Monitoring System  
K073030 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/04/2008
Home Diagnostics TRUEresult Blood Glucose Monitoring System  
K080641 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/20/2008
Acon Laboratories Mission UTI Urinary Tract Infection Test Strips  
K063295 Nitrite, Urine General Chemistry 08/18/2008
Acon Laboratories Mission UTI Urinary Tract Infection Test Strips  
K063295 Leukocyte Esterase, Urinary Urinalysis 08/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
American Bio Medica Rapid TOX  
K053359 Amphetamines Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Cannabinoids (THC) Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Phencyclidine (PCP) Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Cocaine Metabolites Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Opiates Toxicology / TDM 08/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
American Bio Medica Rapid TOX  
K053359 Methadone Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Propoxyphene Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Methamphetamines Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Benzodiazepines Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Barbiturates Toxicology / TDM 08/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
American Bio Medica Rapid TOX  
K053359 Tricyclic Antidepressants Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Oxycodone Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Buprenorphine Toxicology / TDM 08/18/2008
Home Diagnostics TRUE2go Blood Glucose Monitoring System  
K080710 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/15/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Inverness Medical Acceava hCG Urine II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 08/14/2008
Home Diagnostics, Home Care Delivered TrueTrack Smart System Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
Home Diagnostics, Moore Medical TrueTrack Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
Home Diagnostics, TrueTrack for Rite Aid Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
Home Diagnostics, TrueTrack Live Better Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
TaiDoc Technology Corporation U-Right TD-4247 Blood Glucose Monitoring System  
K081957 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Amphetamines Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Phencyclidine (PCP) Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Cocaine Metabolites Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Methadone Toxicology / TDM 07/31/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Methamphetamines Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Benzodiazepines Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Barbiturates Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Morphine Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Tricyclic Antidepressants Toxicology / TDM 07/31/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Oxycodone Toxicology / TDM 07/31/2008
Avnetir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Cannabinoids (THC) Toxicology / TDM 07/31/2008
Fora Care AudioChek Talking Mointors Blood Glucose Monitoring System Model TD-4237  
K081609 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
Fora Care Clever Chek TD-4237 Blood Glucose Monitoring System  
K081609 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
Fora Care Inc. FORA TD-3224 Blood Glucose Plus Blood Pressure Monitoring System  
K081714 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Gluco Perfect LLC, Perfect Mini Blood Glucose Monitoring System  
K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
BTNX Inc. Rapid Response Immunological Fecal Occult Blood Test (IFOBT)  
K061065 Fecal Occult Blood General Chemistry 07/22/2008
Healthcare Provider Direct OneStep Fecal Occult Blood (FOB) Screen Card Test  
K063693 Fecal Occult Blood General Chemistry 07/22/2008
Roche Diagnostics ACCU-CHEK Compact Plus Blood Glucose Meter  
K081389 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/22/2008
Arkray USA, Inc. GLUCOCARD 01 Blood Glucose Monitoring System  
K073416 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Henry Schein One Step+ Strep A Dipstick Test  
K010582 Streptococcus, Group A Bacteriology 07/17/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 07/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Blood Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Protein Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick pH Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/14/2008
Inverness Medical Acceava hCG Basic II  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 07/14/2008
Inverness Medical Acceava hCG Combo II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 07/14/2008
BECKMAN COULTER HEMOCCULT ICT  
K080812 Fecal Occult Blood General Chemistry 07/01/2008
Germaine Laboratories Compliance Gold iFOB (immunological fecal occult blood)Test  
K063693 Fecal Occult Blood General Chemistry 07/01/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IDEAL LIFE Gluco-Manager GMM 0001 Blood Glucose Monitoring System  
K080283 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Tyson Bioresearch Inc. Diachex Basic Blood Glucose Monitoring System  
K072854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Tyson Bioresearch Inc. Diachex Superb Blood Glucose Monitoring System  
K072854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Tyson Bioresearch Inc. Diachex Vigor Blood Glucose Monitoring System  
K072854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Germaine Laboratories AimStrip Pregnancy  
K974368 Urine hCG By Visual Color Comparison Tests Endocrinology 06/26/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
AZO Test Strips Urinary Tract Infection Test  
K063295 Nitrite, Urine General Chemistry 06/25/2008
AZO Test Strips Urinary Tract Infection Test  
K063295 Leukocyte Esterase, Urinary Urinalysis 06/25/2008
Simple Diagnostics Clever Chek Auto-Code Voice Blood Glucose Monitoring System  
K081144 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/23/2008
HemoCue Albumin 201 System  
K053253 Albumin, Urinary General Chemistry 06/13/2008
SpermCheck Vasectomy  
K073039 Semen Hematology 06/12/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Ketone Urinalysis 05/28/2008
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Bilirubin Urinalysis 05/28/2008
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Blood Urinalysis 05/28/2008
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Glucose Urinalysis 05/28/2008
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Leukocytes Urinalysis 05/28/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Nitrite Urinalysis 05/28/2008
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick pH Urinalysis 05/28/2008
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Protein Urinalysis 05/28/2008
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/28/2008
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Specific Gravity Urinalysis 05/28/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Henry Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 05/28/2008
Specialty Medical Supplies SureChek Edge Blood Glucose Monitoring System  
K080501 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Taidoc Technology ACHTUNG TD-4207 No Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Taidoc Technology CLEVER CHEK TD-4209 One-Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
TaiDoc Technology CLEVER CHEK TD-4222 No Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Taidoc Technology CLEVER CHEK TD-4225 No Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Taidoc Technology CLEVER CHEK TD-4226 One-Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Diagnostic Test Group Clarity Ketone Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 2 GP Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 2 GP Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 05/19/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 05/19/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Home Diagnostics, Preferred Plus Pharmacy TRUEread Blood Glucose Monitoring System  
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/29/2008
AgaMatrix WaveSense KeyNote Pro Blood Glucose Monitoring System  
K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2008
AgaMatrix WaveSense Presto Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2008
Target Corporation, EasyPRO Plus Blood Glucose Monitoring System  
K063068 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2008
Apex Biotechnology Corp. GlucoSure Voice Blood Glucose Monitoring System  
K073137 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LifeScan One Touch UltraLink Blood Glucose Monitoring System  
K073231 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008
Neuero Engineering Inc. 3test Supreme Glucose Monitoring System  
K072905 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008
Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K023639 Triglyceride General Chemistry 04/14/2008
Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K023640 HDL Cholesterol General Chemistry 04/14/2008
Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K023642 Cholesterol General Chemistry 04/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K023640 HDL Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole blood)
K023640 HDL Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K023639 Triglyceride General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole blood)
K023639 Triglyceride General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K023642 Cholesterol General Chemistry 04/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole blood)
K023642 Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole blood)
K950164 Alkaline Phosphatase (ALP) General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole blood)
K950164 Amylase General Chemistry 04/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K942782 Glucose General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole blood)
K942782 Albumin General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole blood)
K942782 Protein, Total General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole blood)
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole blood)
K942782 Bilirubin, Total General Chemistry 04/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagenr Disc} (Whole blood)
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole blood)
K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 04/14/2008
Apex Biotechnology Corp. GlucoSure Star Blood Glucose Monitoring System  
K073648 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008
Tyson Bioresearch Inc. Diachex+ Determine Blood Glucose Monitoring System  
K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008
Tyson Bioresearch, Inc., Diachex+ Infinity Blood Glucose Monitoring System  
K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Strep A Rapid Test Strips  
K983386 Streptococcus, Group A Bacteriology 04/08/2008
Bayer A1CNow +  (For professional use)
K051321 Glycated Hemoglobin, Total General Chemistry 03/31/2008
Fora Care Inc. Fora Comfort 2 in 1 Blood Glucose Plus Blood Pressure Monitoring System TD-3250  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2008
HMD Biomedical Llc Evolution Blood Glucose Monitoring System  
K072369 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2008
Inverness Medical Professional Diagnostics BioStar Acceava hCG Urine II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 03/26/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Tyson Bioresearch, Inc. EZ Scan Plus Blood Glucose Monitoring System  
K072441 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2008
Inverness Medical BioStar Acceava Strep A Twist {Strep A} 
K023766 Streptococcus, Group A Bacteriology 03/19/2008
Jant Pharmacal Accutest Integrated Strep A Rapid Test Device {Strep A} 
K023766 Streptococcus, Group A Bacteriology 03/19/2008
Moore Medical The Supply Experts Strep A Test - Cassette {Strep A} 
K023766 Streptococcus, Group A Bacteriology 03/19/2008
AmeriTek dBest One Step Occult Blood Test  
K071242 Fecal Occult Blood General Chemistry 03/12/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Devices Prodigy Voice Blood Glucose Monitoring System  
K073118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2008
Diagnostic Test Group, Clarity Blood Glucose Monitoring System  
K062829 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2008
Bestgen Major III Blood Glucose Monitoring System  
K072274 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/04/2008
Henry Schein One Step + Strep A Cassette Test  
K023766 Streptococcus, Group A Bacteriology 03/04/2008
TaiDoc Clever Chek TD-4232 Blood Glucose Monitoring System  
K073119 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Qualigen, Inc. FastChek TSH  (Whole blood)
K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 02/29/2008
Nova Biomedical Corp. StatStrip Glucose Hospital Meter  
K060345 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 02/28/2008
Nova Biomedical, Nova Max Link Blood Glucose Monitoring System  
K040603 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/28/2008
Henry Schein One Step + Mononucleosis Rapid Test Device  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/26/2008
Quidel QuickVue RSV Test  
K061008 Respiratory Syncytial Virus Virology 02/25/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Quidel QuickVue RSV Test  
K070747 Respiratory Syncytial Virus Virology 02/25/2008
Clarity MONO Mononucleosis Rapid Test  (Whole blood)
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/13/2008
AgaMatrix WaveSense KeyNote Codeless Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/31/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Amphetamines Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cannabinoids (THC) Toxicology / TDM 01/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Phencyclidine (PCP) Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cocaine Metabolites Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methadone Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methamphetamines Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Benzodiazepines Toxicology / TDM 01/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Barbiturates Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Morphine Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Tricyclic Antidepressants Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Amphetamines Toxicology / TDM 01/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cannabinoids (THC) Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Phencyclidine (PCP) Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cocaine Metabolites Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methadone Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methamphetamines Toxicology / TDM 01/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Benzodiazepines Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Barbiturates Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Morphine Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Tricyclic Antidepressants Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
JANT Pharmacal Corporation Accutest Value + Urine Pregnancy Test Device  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 01/30/2008
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Amphetamines Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Cannabinoids (THC) Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Phencyclidine (PCP) Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Cocaine Metabolites Toxicology / TDM 01/23/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Benzodiazepines Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Barbiturates Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)   
K070009 Opiates Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)   
K070009 Methadone Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)   
K070009 Methamphetamines Toxicology / TDM 01/23/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Phamatech At Home 12 Drug Test (Model 9308T)   
K070009 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Amphetamines Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Cannabinoids (THC) Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Phencyclidine (PCP) Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Cocaine Metabolites Toxicology / TDM 01/23/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Opiates Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Methadone Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Methamphetamines Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Benzodiazepines Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Barbiturates Toxicology / TDM 01/23/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Oxycodone Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 930T)   
K070009 Oxycodone Toxicology / TDM 01/23/2008
Becton Dickinson BD Chek Group A Strep Test  
K010582 Streptococcus, Group A Bacteriology 01/22/2008
Diagnostic Test Group Clarity H. pylori Rapid Test Device  (Whole blood)
K980798 Helicobacter Pylori Antibodies General Immunology 01/22/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response H. pylori Whole Blood Rapid Test Device  
K024360 Helicobacter Pylori Antibodies General Immunology 01/15/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Amphetamines Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Cannabinoids (THC) Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Phencyclidine (PCP) Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Cocaine Metabolites Toxicology / TDM 01/08/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Opiates Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Propoxyphene Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Benzodiazepines Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Barbiturates Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Tricyclic Antidepressants Toxicology / TDM 01/08/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Oxycodone Toxicology / TDM 01/08/2008
Accutech CholesTrak HDL Cholesterol Home Test  
K072836 HDL Cholesterol General Chemistry 01/08/2008
Diagnostic Devices, Inc. Prodigy Autocode Blood Glucose Monitoring System  
K072784 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/08/2008
Jant Pharmacal Accutest Value + Mononucleosis Rapid Test  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/08/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Stanbio Rely Mono Rapid Test  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/08/2008
TaiDoc Technology Corporation Clever Chek TD-4227 Blood Glucose Monitoring System  
K072784 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/08/2008
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {midstream} (OTC)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {cassette} (OTC)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {strip} (OTC)
K071930 hCG, Urine Endocrinology 12/19/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {cassette} (professional use)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {midstream} (professional)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {strip} (professional)
K071930 hCG, Urine Endocrinology 12/19/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Amphetamines Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Cannabinoids (THC) Toxicology / TDM 12/13/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Phencyclidine (PCP) Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Cocaine Metabolites Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Opiates Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Methamphetamines Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/13/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
EPS Bio Technology EasyPlus mini Self Monitoring Blood Glucose System  
K070053 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/06/2007
Gluco Perfect L.L.C., Gluco Perfect 2 Blood Glucose Monitoring System  
K062799 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/06/2007
Jant Pharmacal Accutest Value + H. pylori Rapid Test Device  (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 11/26/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Ketone Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Bilirubin Urinalysis 11/16/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Glucose Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Nitrite Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Blood Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Leukocytes Urinalysis 11/16/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick pH Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Protein Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/16/2007
JANT Pharmacal Corporation Accutest Value + Urine/Serum Pregnancy Test Device   
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 11/16/2007
Vertex Diagnostics UltraTRAK Blood Glucose Monitoring System  
K062235 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/16/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Ketone Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Bilirubin Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Blood Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Glucose Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Leukocytes Urinalysis 11/08/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick pH Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Protein Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax   
K061742 Urine Qualitative Dipstick Nitrite Urinalysis 11/08/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Macherey-Nagel URYXXON Relax   
K061742 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/08/2007
BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens and Nasal Swabs (NS))
K062109 Influenza A/B Virology 11/01/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K010670 chloride General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K010670 chloride General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole blood)
K010670 chloride General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Albumin General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Protein, Total General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Calcium, Total General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Glucose General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Sodium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Creatinine General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Alkaline Phosphatase (ALP) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Urea (BUN) General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Bilirubin, Total General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K993211 Calcium, Total General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K993211 Glucose General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K993211 Sodium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K993211 Creatinine General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K993211 Urea (BUN) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole blood)
K993211 Sodium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K992140 potassium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K992140 potassium General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Reagent Disc} (Whole blood)
K992140 potassium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Reagent Disc} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Protein, Total General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Calcium, Total General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Creatinine General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Urea (BUN) General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K993211 Calcium, Total General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K993211 Creatinine General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K993211 Urea (BUN) General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Albumin General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Glucose General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Sodium General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Alkaline Phosphatase (ALP) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K993211 Bilirubin, Total General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K993211 Glucose General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K993211 Sodium General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole blood)
K993211 Sodium General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc,} (Whole blood)
K992140 potassium General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Reagent Disc} (Whole blood)
K992140 potassium General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Reagent Disc} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc,} (Whole blood)
K992140 potassium General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole blood)
K010670 chloride General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole blood)
K010670 chloride General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole blood)
K010670 chloride General Chemistry 10/30/2007
Gluco Perfect, L.L.C. Gluco Perfect Blood Glucose Monitoring System  
K032029 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
QuantRx Biomedical QuantRx Female Fertility Test  
K070484 Follicle Stimulating Hormone (FSH) Endocrinology 10/29/2007
PSS World Medical Select Diagnostics hCG Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 10/25/2007
Heritage House '76 Inc., The Precious Feet Premium Pregnancy Test  
K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 10/24/2007
Abbott Diabetes Care Inc. Precision Xceed Pro Glucose Monitoring System  
K022941 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/22/2007
Clearview COMPLETE HIV 1/2  (Fingerstick Veinipuncture, whole blood, )
BP050009 HIV-1 and HIV-2 Antibodies General Immunology 10/22/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Kidney Check Panel} (Whole blood)
K942782 Creatinine General Chemistry 10/18/2007
Abaxis Piccolo xpress Chemistry Analyzer {Kidney Check Panel} (Whole blood)
K942782 Urea (BUN) General Chemistry 10/18/2007
ACON Laboratories UTI Urinary Tract Infection Test Strips  
K063295 Nitrite, Urine General Chemistry 10/15/2007
ACON Laboratories UTI Urinary Tract Infection Test Strips  
K063295 Leukocyte Esterase, Urinary Urinalysis 10/15/2007
Duramed Pharmaceuticals, Inc. AmniScreen Home Detection Liner Kit  
K071100 Vaginal pH General Chemistry 10/15/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL Panel Test Strips} 
K071593 Cholesterol General Chemistry 10/15/2007
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL Panel Test Strips} 
K071593 HDL Cholesterol General Chemistry 10/15/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Panel Test Strips} 
K071593 HDL Cholesterol General Chemistry 10/15/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Panel Test Strips} 
K071593 Cholesterol General Chemistry 10/15/2007
Tyson Bioresearch, Inc. Ultimate EZ Smart Plus Blood Glucose Monitoring System  
K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/15/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Lifescan, Inc. OneTouch Select Meter  
K072543 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/11/2007
Siemens Medical Diagnostics DCA Vantage Analyzer  
K071466 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 10/11/2007
BTNX Inc. Clarity Fecal Occult Blood (FOB) Self Test  
K070660 Fecal Occult Blood General Chemistry 10/05/2007
BTNX Inc. Know Fecal Occult Blood (FOB) Self Test  
K070660 Fecal Occult Blood General Chemistry 10/05/2007
BTNX Inc. Rapid Response Fecal Occult Blood (FOB) Self Test  
K070660 Fecal Occult Blood General Chemistry 10/05/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
TaiDoc Advocate Redi-Code Blood Glucose Monitoring System  
K072039 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/04/2007
AgaMatrix WaveSense Jazz Blood Glucose Monitoring System  
K072413 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/02/2007
Abbott i-STAT CHEM8+ Catridge  (Venous whole blood)
K053110 Hemoglobin Hematology 09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous whole blood)
K053110 Glucose General Chemistry 09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous whole blood)
K053110 Sodium General Chemistry 09/21/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott i-STAT CHEM8+ Catridge  (Venous whole blood)
K053110 potassium General Chemistry 09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous whole blood)
K053110 Calcium, Ionized General Chemistry 09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous whole blood)
K053110 Creatinine General Chemistry 09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous whole blood)
K053110 Urea (BUN) General Chemistry 09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous whole blood)
K053110 chloride General Chemistry 09/21/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott i-STAT CHEM8+ Catridge  (Venous whole blood)
K053110 Carbon Dioxide, Total (CO2) General Chemistry 09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous whole blood)
K053110 Hematocrit Hematology 09/21/2007
Abbott Laboratories Signify hCG Urine Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 09/21/2007
Moore Medical The Supply Experts hCG Urine -Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 09/21/2007
Moore Medical The Supply Experts hCG Urine-Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 09/21/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507 HDL Cholesterol General Chemistry 09/21/2007
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507 Glucose General Chemistry 09/21/2007
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507 Cholesterol General Chemistry 09/21/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507 Glucose General Chemistry 09/21/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507 Cholesterol General Chemistry 09/21/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507 HDL Cholesterol General Chemistry 09/21/2007
TaiDoc REVOLUTION TD-4229 Blood Glucose Monitoring System  
K072489 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/21/2007
US Diagnostics, Inc. Maxima Blood Glucose Monitoring System  
K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/20/2007
Polymedco Poly Stat Strep A Dipstick  
K010582 Streptococcus, Group A Bacteriology 09/18/2007
Abbott Laboratories Signify H. pylori Cassette  (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 09/11/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
AI DE Diagnostic Co. One Step HCG Serum/Urine Combo Pregnancy Test (Cassette Style)  
K062703 Urine hCG By Visual Color Comparison Tests Endocrinology 09/11/2007
AI DE Diagnostic Co. One Step HCG Serum/Urine Combo Pregnancy Test (Strip Style)  
K062703 Urine hCG By Visual Color Comparison Tests Endocrinology 09/11/2007
AI DE Diagnostic Co. One Step HCG Urine Pregnancy Test (Cassette Style)  
K062703 Urine hCG By Visual Color Comparison Tests Endocrinology 09/11/2007
AI DE Diagnostic Co. One Step HCG Urine Pregnancy Test (Midstream)  
K062703 Urine hCG By Visual Color Comparison Tests Endocrinology 09/11/2007
AI DE Diagnostic Co. One Step HCG Urine Pregnancy Test (Strip Style)  
K062703 Urine hCG By Visual Color Comparison Tests Endocrinology 09/11/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Inverness Medical Professional Diagnostics Clearview 25 hCG Combo  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 08/24/2007
Inverness Medical Professional Diagnostics Signify hCG Combo Cassette  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 08/24/2007
Moore Medical The Supply Experts hCG Serum/Urine Test-Cassette  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 08/24/2007
Polymedco, Inc. Poly stat hCG Test (Urine/Serum)  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 08/24/2007
Abbott Laboratories Signify Strep A Dipstick  
K010582 Streptococcus, Group A Bacteriology 08/21/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accustrip Strep A Value+ Test Strip  
K010582 Streptococcus, Group A Bacteriology 08/21/2007
JANT Pharmacal Corp. Accustrip Value+ hCG One Step Pregnancy Test Strip (Urine)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 08/17/2007
Henry Schein, Inc. One Step + hCG Combo Test  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 08/16/2007
Henry Schein, Inc. One Step + hCG Urine Cassette Test  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 08/16/2007
Henry Schein, Inc. One Step + hCG Urine Strip Test  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 08/16/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Lightstar Enterprises, Inc. GlucoTest Excel Blood Glucose Monitoring System  
K043512 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/16/2007
Moore Medical The Supply Experts Strep A Rapid Test - Dipstick  
K010582 Streptococcus, Group A Bacteriology 08/14/2007
Arkray GLUCOCARD X-METER Blood Glucose Monitoring System  
K063771 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2007
Physicians Medical Supply Quick Chek ultra Blood Glucose Monitoring System  
K062235 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2007
Jant Pharmacal Accutest SplitCup  (professional use)
K050878 Amphetamines Toxicology / TDM 08/07/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest SplitCup  (professional use)
K050878 Cannabinoids (THC) Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest SplitCup  (professional use)
K050878 Phencyclidine (PCP) Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest SplitCup  (professional use)
K050878 Cocaine Metabolites Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest SplitCup  (professional use)
K050878 Opiates Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest SplitCup  (professional use)
K050878 Methamphetamines Toxicology / TDM 08/07/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest SplitCup  (professional use)
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/07/2007
AgaMatrix Jazz Blood Glucose Monitoring System  
K071393 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2007
Exir Pharmaceutical Maximed Exichek TD-4224 Blood Glucose Monitoring System  
K070239 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2007
Henry Schein One Step + H. Pylori Rapid Test Device {Whole blood} (H. Pylori)
K024350 Helicobacter Pylori Antibodies General Immunology 07/25/2007
Polymedco Poly Stat H. Pylori Test {Whole blood} (H. Pylori)
K024350 Helicobacter Pylori Antibodies General Immunology 07/25/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Cardinal Health SP Brand Rapid Test hCG Combo  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 07/12/2007
Clearview MONO Whole Blood  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/12/2007
HENRY SCHEIN ONE STEP+ MONO TEST  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/12/2007
Inverness Medical Clearview hCG Combo II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 07/12/2007
Poly Stat Mono Test  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/12/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PSS World Medical Select Diagnostics hCG Combo Cassette  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 07/12/2007
PSS World Medical Select Diagnostics hCG Urine Cassette  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 07/12/2007
Signify Mono Cassette  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/12/2007
Home Diagnostics, facil TRUEread Blood Glucose Monitoring System  
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2007
Home Diagnostics, Good Neighbor Pharmacy TRUEread Blood Glucose Monitoring System   
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Home Diagnostics, Invacare TRUEread Blood Glucose Monitoring System   
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2007
Home Diagnostics, Leader TRUEread Blood Glucose Monitoring System   
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2007
Home Diagnostics, sunmark TRUEread Blood Glucose Monitoring System   
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2007
Applied DNA Technologies Bionexia hCG Pregnancy Cassette and Dipstick Tests  
K070921 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2007
Bionexia hCG Pregnancy Serum/Urine Cassette and Dipstick Tests  
K071030 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Select Diagnostics Rapid Test Mono Cassette  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/02/2007
Visgeneer, Inc. eBsensor Blood Glucose Monitoring System  
K062555 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/02/2007
Alfa Scientific Designs Fecal Occult Blood (FOB) Self-Test  
K070660 Fecal Occult Blood General Chemistry 06/28/2007
Alfa Scientific Designs Instant-View Fecal Occult Blood (FOB) Self-Test  (cassette)
K070660 Fecal Occult Blood General Chemistry 06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Amphetamines Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Cannabinoids (THC) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Phencyclidine (PCP) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Cocaine Metabolites Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Methadone Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Methamphetamines Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Benzodiazepines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Barbiturates Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Morphine Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Tricyclic Antidepressants Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Amphetamines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Cannabinoids (THC) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Phencyclidine (PCP) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Cocaine Metabolites Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Methadone Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Methamphetamines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Benzodiazepines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Barbiturates Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Morphine Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Tricyclic Antidepressants Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test  
K063545 Amphetamines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test  
K063545 Cannabinoids (THC) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test  
K063545 Phencyclidine (PCP) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test  
K063545 Cocaine Metabolites Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test  
K063545 Methadone Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test  
K063545 Benzodiazepines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test  
K063545 Barbiturates Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test  
K063545 Morphine Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test  
K063545 Tricyclic Antidepressants Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test  
K063545 Amphetamines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test  
K063545 Cannabinoids (THC) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test  
K063545 Phencyclidine (PCP) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test  
K063545 Cocaine Metabolites Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test  
K063545 Methadone Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test  
K063545 Benzodiazepines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test  
K063545 Barbiturates Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test  
K063545 Morphine Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test  
K063545 Tricyclic Antidepressants Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Amphetamines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Cannabinoids (THC) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Phencyclidine (PCP) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Cocaine Metabolites Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Methadone Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Methamphetamines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Benzodiazepines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Barbiturates Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Morphine Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Tricyclic Antidepressants Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Amphetamines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Cannabinoids (THC) Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Phencyclidine (PCP) Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Cocaine Metabolites Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Methadone Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Methamphetamines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Benzodiazepines Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Barbiturates Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Morphine Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Tricyclic Antidepressants Toxicology / TDM 06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/28/2007
Arkray, PocketChem EZ Blood Glucose Monitoring System  
K063068 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/28/2007
Cardinal Health SP Brand Rapid Test hCG Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Cardinal Health SP Brand Rapid Test hCG Combo Cassette  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2007
Cardinal Health SP Brand Rapid Test hCG Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Amphetamines Toxicology / TDM 06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Cannabinoids (THC) Toxicology / TDM 06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Phencyclidine (PCP) Toxicology / TDM 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Cocaine Metabolites Toxicology / TDM 06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Opiates Toxicology / TDM 06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Methamphetamines Toxicology / TDM 06/28/2007
Physicians Medical Supply Quick Chek Blood Glucose Monitoring System  
K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/28/2007
PSS World Medical Select Diagnostics Strep A Twist  
K023766 Streptococcus, Group A Bacteriology 06/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Tyson Bioresearch, Inc. EZ Smart-608 Blood Glucose Monitoring System  
K062829 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/28/2007
Cambridge Sensors ltd. microdot Blood Glucose Monitoring System  
K070524 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/25/2007
Kurkel Enterprises Early-Pregnancy-Tests.com Ovulation Midstream Tests  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/25/2007
Kurkel Enterprises Early-Pregnancy-Tests.com Ovulation Test Strips  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/25/2007
PSS World Medical Select Diagnostics Strep A Dipstick  
K010582 Streptococcus, Group A Bacteriology 06/25/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Rush Industries Ovulation Test  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/25/2007
Select Medical Products Brand Rapid Test H. Pylori {Whole Blood Only} (H. Pylori)
K024350 Helicobacter Pylori Antibodies General Immunology 06/25/2007
Fertell Male Fertility Test   
K041039 Semen Hematology 06/18/2007
Nova Biomedical Nova Max Blood Glucose Monitoring System  
K070255 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/18/2007
Fisher Healthcare Sure-Vue H. pylori Test  (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 06/11/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Inverness Medical Profesional Diagnostics Signify H. pylori Test  (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 06/11/2007
McKesson Medi-Lab Performance H. pylori Test  (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 06/11/2007
Savyon Diagnostics Uriscreen {Bacteriuria} 
K882211 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 06/11/2007
PSS World Medical Select hCG Cassette  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 06/01/2007
PSS World Medical Select hCG Combo  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 06/01/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PSS World Medical Select hCG Dipstick  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 06/01/2007
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole blood)
K050652 Creatinine General Chemistry 05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole blood)
K053401 Protein, Total General Chemistry 05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole blood)
K053401 Albumin General Chemistry 05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole blood)
K053401 Calcium, Total General Chemistry 05/31/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole blood)
K053401 Glucose General Chemistry 05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole blood)
K053401 Creatinine General Chemistry 05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole blood)
K053401 Urea (BUN) General Chemistry 05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole blood)
K053401 Protein, Total General Chemistry 05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole blood)
K053401 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 05/31/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole blood)
K053401 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole blood)
K053401 Alkaline Phosphatase (ALP) General Chemistry 05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole blood)
K053401 Bilirubin, Total General Chemistry 05/31/2007
Cardinal Health, SP Brand Rapid Test Mono  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 05/31/2007
Roche Diagnostics Corp. ACCU-CHEK Performa System  
K070585 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/31/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
SA Scientific SAS Pregnancy Serum/Urine Test  
K010593 Urine hCG By Visual Color Comparison Tests Endocrinology 05/31/2007
Cardinal Health SP Brand Rapid Test H. Pylori {H. Pylori} (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 05/24/2007
Cardinal Health SP Brand Rapid Test Strep A Dipstick  
K010582 Streptococcus, Group A Bacteriology 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Amphetamines Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Cannabinoids (THC) Toxicology / TDM 05/24/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Phencyclidine (PCP) Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Cocaine Metabolites Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Opiates Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Propoxyphene Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Benzodiazepines Toxicology / TDM 05/24/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Barbiturates Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Tricyclic Antidepressants Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Oxycodone Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Amphetamines Toxicology / TDM 05/24/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Cannabinoids (THC) Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Phencyclidine (PCP) Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Cocaine Metabolites Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Opiates Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Propoxyphene Toxicology / TDM 05/24/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Benzodiazepines Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Barbiturates Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Tricyclic Antidepressants Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Oxycodone Toxicology / TDM 05/24/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Immuno Detector Mono {Whole blood} 
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 05/17/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole blood)
K922612 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 05/16/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole blood)
K922612 Triglyceride General Chemistry 05/16/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole blood)
K922612 HDL Cholesterol General Chemistry 05/16/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole blood)
K922612 Cholesterol General Chemistry 05/16/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test  
K063693 Fecal Occult Blood General Chemistry 05/16/2007
Immunostics Detector H. pylori WB {H. pylori Antiboby Test} (For whole blood)
K980798 Helicobacter Pylori Antibodies General Immunology 05/16/2007
KoreaMedico Chextic  
K062096 Urine hCG By Visual Color Comparison Tests Endocrinology 05/10/2007
McKesson Medi-Lab Performance Strep A Test - Twist  
K023766 Streptococcus, Group A Bacteriology 05/10/2007
PerMaxim RediScreen Strep A Twist Cassette  
K023766 Streptococcus, Group A Bacteriology 05/10/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
AmeriTek USA, dBest One Step hCG Panel Test Kit  
K061257 Urine hCG By Visual Color Comparison Tests Endocrinology 05/07/2007
Church & Dwight Co., Inc. FIRST RESPONSE Gold Digital Pregnancy Test  
K070054 Urine hCG By Visual Color Comparison Tests Endocrinology 05/07/2007
Diacare Corp. EASY CHECK Blood Glucose Monitoring System  
K062538 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/02/2007
Taidoc Technology easi check precise Blood Glucose Monitoring System  
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/02/2007
Abbott Diabetes Care Inc., FreeStyle Lite Glucose Monitoring System  
K070850 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/12/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response Blood Glucose Monitoring System  
K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/12/2007
Clearview MONO Whole Blood  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/12/2007
Diabetic Supply of Suncoast, Inc. Advocate Duo Blood Glucose Plus Blood Pressure Monitoring System  
K070641 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/12/2007
HemoCue Hb 301 System  
K061047 Hemoglobin Hematology 04/12/2007
Medi-Lab Performance Infectious Mononucleosis Test  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/12/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Signify Mono Whole Blood  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/12/2007
Fisher HealthCare Sure-Vue Serum/Urine hCG-STAT  
K062361 hCG, Urine Endocrinology 04/02/2007
Jant Pharmacal Corporation Accutest TSH  (Whole blood)
K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 04/02/2007
Bionime Corporation Rightest Blood Glucose Monitoring System  
K062567 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/29/2007
Fisher HealthCare Sure-Vue Urine hCG  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 03/29/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Redwood Toxicology Laboratory Reditest Home Drug Test  
K050878 Amphetamines Toxicology / TDM 03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test  
K050878 Cannabinoids (THC) Toxicology / TDM 03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test  
K050878 Phencyclidine (PCP) Toxicology / TDM 03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test  
K050878 Cocaine Metabolites Toxicology / TDM 03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test  
K050878 Opiates Toxicology / TDM 03/29/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Redwood Toxicology Laboratory Reditest Home Drug Test  
K050878 Methamphetamines Toxicology / TDM 03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test  
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/29/2007
Fisher HealthCare Sure-Vue Serum/Urine hCG  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 03/28/2007
Fisher HealthCare Sure-Vue Strep A Test  
K010582 Streptococcus, Group A Bacteriology 03/28/2007
Home Diagnostics, TRUEread Blood Glucose Monitoring System  
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/28/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Mckesson Medi-Lab Strep A Test - Dipstick  
K010582 Streptococcus, Group A Bacteriology 03/28/2007
McKesson Medical-Surgical Medi-Lab Performance hCG Combo Test-Cassette  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 03/28/2007
SA Scientific SAS Pregnancy Urine Test  
K010522 Urine hCG By Visual Color Comparison Tests Endocrinology 03/28/2007
Roche Diagnostics CoaguChek XS   
K060978 Prothrombin Time (PT) Hematology 03/23/2007
Kurkel Enterprises Early-Pregnancy-Tests.com Pregnancy Midstream Tests  
K974059 Urine hCG By Visual Color Comparison Tests Endocrinology 03/19/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Kurkel Enterprises Early-Pregnancy-Tests.com Pregnancy Test Strips  
K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 03/19/2007
Rush Industries Rush Pregnancy Test  
K974059 Urine hCG By Visual Color Comparison Tests Endocrinology 03/19/2007
TaiDoc Clever Chek Blood Glucose Monitoring System TD-4230  
K070472 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/19/2007
TaiDoc SureChek Blood Glucose Monitoring System  
K070472 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/19/2007
Bayer Clinitek Status Urine Chemistry Analyzer  
K032563 hCG, Urine Endocrinology 03/16/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K934592 Uric Acid General Chemistry 03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K950164 Calcium, Total General Chemistry 03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Albumin General Chemistry 03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Protein, Total General Chemistry 03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 03/14/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Glucose General Chemistry 03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Creatinine General Chemistry 03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Urea (BUN) General Chemistry 03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Bilirubin, Total General Chemistry 03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 03/14/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K942782 Glucose General Chemistry 03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K942782 Creatinine General Chemistry 03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K942782 Urea (BUN) General Chemistry 03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K942782 Glucose General Chemistry 03/14/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K942782 Creatinine General Chemistry 03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K942782 Urea (BUN) General Chemistry 03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Albumin General Chemistry 03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Protein, Total General Chemistry 03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 03/14/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Glucose General Chemistry 03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Creatinine General Chemistry 03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Urea (BUN) General Chemistry 03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K942782 Bilirubin, Total General Chemistry 03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K950164 Calcium, Total General Chemistry 03/14/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K934592 Uric Acid General Chemistry 03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (professional use)
K050050 Amphetamines Toxicology / TDM 03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (professional use)
K050050 Cannabinoids (THC) Toxicology / TDM 03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (professional use)
K050050 Phencyclidine (PCP) Toxicology / TDM 03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (professional use)
K050050 Cocaine Metabolites Toxicology / TDM 03/14/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (professional use)
K050050 Opiates Toxicology / TDM 03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (professional use)
K050050 Methamphetamines Toxicology / TDM 03/14/2007
SA Scientific SAS Pregnancy Serum/Urine Test  
K010593 Urine hCG By Visual Color Comparison Tests Endocrinology 03/14/2007
Fisher HealthCare Sure-Vue Urine hCG Strip  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 03/07/2007
Innovacon FOB Flipcard Fecal Occult Blood Test  
K063673 Fecal Occult Blood General Chemistry 03/07/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
McKesson Medical-Surgical, Medi-Lab Performance hCG Urine Test - Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 03/07/2007
McKesson Medical-Surgical, Medi-Lab Performance hCG Urine Test - Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 03/07/2007
Tyson Bioresearch, Inc. SMARTCHEX Blood Glucose Monitoring System  
K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/07/2007
Roche Diagnostics Accu-Chek Inform System  (professional use)
K003846 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2007
Roche Diagnostics CoaguChek XS PST  
K062925 Prothrombin Time (PT) Hematology 02/26/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Apex Biotechnology Corp. Assure 4 Blood Glucose Monitoring System  
K070088 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/22/2007
Innovacon Integrated E-Z Split Key Cup II  (professional use)
K050878 Amphetamines Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (professional use)
K050878 Cannabinoids (THC) Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (professional use)
K050878 Phencyclidine (PCP) Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (professional use)
K050878 Cocaine Metabolites Toxicology / TDM 02/22/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Innovacon Integrated E-Z Split Key Cup II   (professional use)
K050878 Opiates Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (professional use)
K050878 Methamphetamines Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (professional use)
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/22/2007
Inverness Medical Professional Devices Clearview hCG Urine Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Inverness Medical Professional Diagnostics Clearview hCG Combo II  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Inverness Medical Professional Diagnostics Clearview hCG Urine Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Inverness Medical Professional Diagnostics Signify hCG Combo Urine/Serum  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Inverness Medical Professional Diagnostics Signify hCG Urine Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Inverness Medical Professional Diagnostics Signify hCG Urine Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Ok Biotech Co., Ltd. Ok Meter Blood Glucose Monitoring System  
K063026 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/13/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Inverness Medical Clearview Strep A Exact II Dipstick  
K010582 Streptococcus, Group A Bacteriology 02/08/2007
Select Diagnostics Immunochemical Fecal Occult Blood Test  
K060463 Fecal Occult Blood General Chemistry 02/08/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Ketone Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Bilirubin Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Blood Urinalysis 02/07/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Glucose Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Leukocytes Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Nitrite Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick pH Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Protein Urinalysis 02/07/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 02/07/2007
Inverness Medical Clearview H. pylori Test  (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 02/07/2007
Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} 
K070017 Triglyceride General Chemistry 02/07/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} 
K070017 HDL Cholesterol General Chemistry 02/07/2007
Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} 
K070017 Glucose General Chemistry 02/07/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} 
K070017 Triglyceride General Chemistry 02/07/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} 
K070017 HDL Cholesterol General Chemistry 02/07/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} 
K070017 Glucose General Chemistry 02/07/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Apex Biotechnology Corp. Gluco Track Blood Glucose Monitoring System  
K062799 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/05/2007
TaiDoc Advocate Blood Glucose Monitoring System  
K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/31/2007
Teco Diagnostics Microalbumin 2-1 Combo Strip  
K061419 Urine Qualitative Dipstick Protein Urinalysis 01/29/2007
Teco Diagnostics Microalbumin 2-1 Combo Strip  
K061419 Urine Qualitative Dipstick Creatinine Urinalysis 01/29/2007
EUKARE Blood Glucose Monitoring System  
K062892 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/26/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
InSure Quik Fecal Immunochemical Test (F.I.T.)  
K060930 Fecal Occult Blood General Chemistry 01/26/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K950164 Alkaline Phosphatase (ALP) General Chemistry 01/22/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K950164 Amylase General Chemistry 01/22/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K950164 Alkaline Phosphatase (ALP) General Chemistry 01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K950164 Amylase General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K950164 Alkaline Phosphatase (ALP) General Chemistry 01/22/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer  
K950164 Amylase General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K942782 Albumin General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K942782 Protein, Total General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K942782 Glucose General Chemistry 01/22/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer  
K942782 Bilirubin, Total General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K023642 Cholesterol General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K023639 Triglyceride General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K023640 HDL Cholesterol General Chemistry 01/22/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Taidoc Technology Corporation Clever Chek TD-3213 Blood Glucose Plus Blood Pressure Monitoring System  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Taidoc Technology Corporation Clever Chek TD-3215 Blood Glucose Plus Blood Pressure Monitoring System  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Taidoc Technology Corporation Clever Chek TD-3217 Blood Glucose Plus Blood Pressure Monitoring System  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Taidoc Technology Corporation Clever Chek TD-3250 Blood Glucose Plus Blood Pressure Monitoring System  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Taidoc Technology Corporation Dr. T TD-3216 Blood Glucose Plus Blood Pressure Monitoring System   
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
US Diagnostics, Inc. EASYGLUCO Glucose Monitoring System  
K061431 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Natureplex, LLC BE CERTAIN Home Pregnancy Test  
K051963 Urine hCG By Visual Color Comparison Tests Endocrinology 01/12/2007
Arkray, Ferrara Blood Glucose Monitoring System  
K063068 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/09/2007
Common Sense Ltd. Fem-V Test Kit  
K043109 Vaginal pH General Chemistry 01/09/2007
Henry Schein Urispec 4-Way Reagent Test Strips  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 01/09/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Henry Schein Urispec 4-Way Reagent Test Strips  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 01/09/2007
Henry Schein Urispec 4-Way Reagent Test Strips  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 01/09/2007
Henry Schein Urispec 4-Way Reagent Test Strips  
K991927 Urine Qualitative Dipstick Protein Urinalysis 01/09/2007
LifeSign, LLC Status hCG Strip  
K950307 Urine hCG By Visual Color Comparison Tests Endocrinology 01/09/2007
ARJ Medical URITEST 10 Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Ketone Urinalysis 12/30/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ARJ Medical URITEST 10 Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Bilirubin Urinalysis 12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Blood Urinalysis 12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Glucose Urinalysis 12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Leukocytes Urinalysis 12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Nitrite Urinalysis 12/30/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ARJ Medical URITEST 10 Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick pH Urinalysis 12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Protein Urinalysis 12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/30/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Amphetamines Toxicology / TDM 12/28/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Cocaine Metabolites Toxicology / TDM 12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Opiates Toxicology / TDM 12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Methamphetamines Toxicology / TDM 12/28/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Amphetamines Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Cocaine Metabolites Toxicology / TDM 12/28/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Opiates Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Methamphetamines Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/28/2006
Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole blood)
K042443 Triglyceride General Chemistry 12/12/2006
Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole blood)
K042443 HDL Cholesterol General Chemistry 12/12/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole blood)
K042443 Cholesterol General Chemistry 12/12/2006
Taidoc Clever Chek Blood Glucose Monitoring System TD-4223  
K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2006
Taidoc Clever Chek Blood Glucose Monitoring System TD-4231  
K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2006
Bayer Diagnostics Ascencia BREEZE 2 Blood Glucose Monitoring System  
K062347 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/22/2006
LifeSign Status Mono  (For whole blood)
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 11/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
All Medicus GlucoDr SuperSensor Blood Glucose Test System  
K050985 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/20/2006
Chembio HIV 1/2 STAT-PAK Assay  (Fingerstick, Venipuncture Whole Blood)
BP050010 HIV Antibodies General Immunology 11/20/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Amphetamines Toxicology / TDM 11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Cannabinoids (THC) Toxicology / TDM 11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Phencyclidine (PCP) Toxicology / TDM 11/14/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Cocaine Metabolites Toxicology / TDM 11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Opiates Toxicology / TDM 11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Methadone Toxicology / TDM 11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Methamphetamines Toxicology / TDM 11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Benzodiazepines Toxicology / TDM 11/14/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Barbiturates Toxicology / TDM 11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Tricyclic Antidepressants Toxicology / TDM 11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K023489 Oxycodone Toxicology / TDM 11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Amphetamines Toxicology / TDM 11/14/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Cannabinoids (THC) Toxicology / TDM 11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Phencyclidine (PCP) Toxicology / TDM 11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Cocaine Metabolites Toxicology / TDM 11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Opiates Toxicology / TDM 11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Methadone Toxicology / TDM 11/14/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Methamphetamines Toxicology / TDM 11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Benzodiazepines Toxicology / TDM 11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Barbiturates Toxicology / TDM 11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Tricyclic Antidepressants Toxicology / TDM 11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/14/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)  
K022355 Oxycodone Toxicology / TDM 11/14/2006
Inverness Medical - BioStar Inc. Acceava hCG Basic II  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 11/14/2006
Planned Parenthood hCG Pregnancy Test Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 11/14/2006
Planned Parenthood hCG Pregnancy Test One Step Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 11/14/2006
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Microalbumin General Chemistry 11/01/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BioStar Acceava Mono II  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 11/01/2006
BTNX Inc Rapid Response H. pylori Rapid Test Device  (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 11/01/2006
GlucoPlus Inc. GlucoPlus Blood Glucose Monitoring System  
K061234 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2006
Innovacon hCG Ultra Test Device  
K062361 hCG, Urine Endocrinology 11/01/2006
Inverness Medical BioStar Acceava Strep A Test  
K010582 Streptococcus, Group A Bacteriology 11/01/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick Ketone Urinalysis 10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick Bilirubin Urinalysis 10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick Blood Urinalysis 10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick Glucose Urinalysis 10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick Leukocytes Urinalysis 10/27/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick Nitrite Urinalysis 10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick pH Urinalysis 10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick Protein Urinalysis 10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/27/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response 11 Parameters Ultra  
K023885 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 10/27/2006
AgaMatrix GRACEpro Blood Glucose Monitoring System  
K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2006
AgaMatrix KeyNote Blood Glucose Monitoring System  
K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2006
Clarity H. pylori Rapid Test Device  (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 10/20/2006
Tyson Bioresearch Inc. DIACHEX Blood Glucose Monitoring System  
K062829 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Genzyme Diagnostics OSOM BVBLUE Test  
K050755 Aerobic/Anaerobic Organisms - Vaginal Bacteriology 10/16/2006
HemoCue Hb 301 System  
K061047 Hemoglobin Hematology 10/10/2006
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole blood)
K041427 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 10/05/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole blood)
K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 10/04/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole blood)
K950164 Alkaline Phosphatase (ALP) General Chemistry 10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole blood)
K950164 Amylase General Chemistry 10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole blood)
K942782 Albumin General Chemistry 10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole blood)
K942782 Protein, Total General Chemistry 10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole blood)
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 10/04/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole blood)
K942782 Bilirubin, Total General Chemistry 10/04/2006
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole blood)
K050077 Urea (BUN) General Chemistry 10/04/2006
Biosite Triage Meterpro  (Whole blood)
K021317 B-Type Natriuretic Peptide (BNP) General Chemistry 10/04/2006
Card Guard Scientific Survival Ltd. SelfCheck Gluco Diabetes Blood Glucose Test System  
K061528 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/04/2006
Little Nell Labs ThyroChek TSH   (Whole blood)
K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 10/04/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
i-Sens Inc. CareSense Blood Glucose Monitoring System  
K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/02/2006
EPS Bio Technology Easy Plus Blood Glucose Monitoring System  
K061992 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/22/2006
OcculTech Fecal Occult Blood Rapid Test  
K060953 Fecal Occult Blood General Chemistry 09/22/2006
ESA Biosciences LeadCare II Blood Lead Testing System  (Whole blood)
K052549 Blood Lead Toxicology / TDM 09/18/2006
Runbio Biotech Co., Ltd. David Pregnancy Test (Midstream)  
K053236 Urine hCG By Visual Color Comparison Tests Endocrinology 09/05/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Runbio Biotech Co., Ltd. David Pregnancy Test (Strip)  
K053236 Urine hCG By Visual Color Comparison Tests Endocrinology 09/05/2006
UltraCrit  
BK050056 Hematocrit Hematology 08/31/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Amphetamines Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 08/21/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Cocaine Metabolites Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Opiates Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Methamphetamine/Amphetamine Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/21/2006
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 08/14/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Blood Urinalysis 08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 08/14/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick pH Urinalysis 08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Protein Urinalysis 08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 08/14/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Teco Rapid Fecal Occult Blood (FOB) Card Test  
K061065 Fecal Occult Blood General Chemistry 08/09/2006
Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana (THC)  
K040327 Cannabinoids (THC) Toxicology / TDM 08/08/2006
Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC)  
K040327 Cannabinoids (THC) Toxicology / TDM 08/08/2006
Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC)  
K040327 Cocaine Metabolites Toxicology / TDM 08/08/2006
WayPoint Biomedical Inc. Health Essist Home Drug Test Marijuana and Cocaine  
K050936 Cocaine Metabolites Toxicology / TDM 08/08/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Waypoint Biomedical, Inc. Health Essist Home Drug Test Marijuana and Cocaine  
K050936 Cannabinoids (THC) Toxicology / TDM 08/08/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL  
K970250 Urine Qualitative Dipstick Ketone Urinalysis 08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL  
K970250 Urine Qualitative Dipstick Bilirubin Urinalysis 08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL  
K970250 Urine Qualitative Dipstick Blood Urinalysis 08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL  
K970250 Urine Qualitative Dipstick Glucose Urinalysis 08/07/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL  
K970250 Urine Qualitative Dipstick Leukocytes Urinalysis 08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL  
K970250 Urine Qualitative Dipstick Nitrite Urinalysis 08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL  
K970250 Urine Qualitative Dipstick pH Urinalysis 08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL  
K970250 Urine Qualitative Dipstick Protein Urinalysis 08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL  
K970250 Urine Qualitative Dipstick Urobilinogen Urinalysis 08/07/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL  
K970250 Urine Qualitative Dipstick Specific Gravity Urinalysis 08/07/2006
ENTERIX INSURE II FECAL IMMUNOCHEMICAL TEST  
K060930 Fecal Occult Blood General Chemistry 08/03/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick Ketone Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick Bilirubin Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick Blood Urinalysis 07/27/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick Glucose Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick Leukocytes Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick Nitrite Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick pH Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick Protein Urinalysis 07/27/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips  
K023885 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick Ketone Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick Bilirubin Urinalysis 07/27/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick Blood Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick Glucose Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick Leukocytes Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick Nitrite Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick pH Urinalysis 07/27/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick Protein Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips  
K023885 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/27/2006
Diagnostic Devices Prodigy Blood Glucose Test System  
K060467 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Home Diagnostics Element Blood Glucose Monitoring System  
K060793 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2006
PerMaxim RediScreen Mononucleosis  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/27/2006
IRIS vChem 10 SG Urine Chemistry Stips  
K861255 Urine Qualitative Dipstick Bilirubin Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ketone Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Blood Urinalysis 07/13/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Leukocytes Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Nitrite Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick pH Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006
IRIS vChem 2 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006
IRIS vChem 2 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IRIS vChem 2 Urine Chemstry Strips  
K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ketone Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Blood Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Leukocytes Urinalysis 07/13/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick pH Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ketone Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Bilirubin Urinalysis 07/13/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Blood Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Nitrite Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick pH Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006
Diagnostic Devices, Inc. Prodigy Blood Glucose Monitoring System  
K053593 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/07/2006
i-Sense Inc. CareSens Blood Glucose Monitoring System  
K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/07/2006
Beckman Coulter ICON HP test  ((for whole blood))
K980798 Helicobacter Pylori Antibodies General Immunology 06/30/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Beckman Coulter ICON SC Strep A test  
K040708 Streptococcus, Group A Bacteriology 06/30/2006
Gryphus Diagnostics BVBlue  
K050755 Aerobic/Anaerobic Organisms - Vaginal Bacteriology 06/30/2006
PFIZER CONSUMER HEALTHCARE e.p.t. Certainty 1-Step Pregnancy Test  
K061769 Urine hCG By Visual Color Comparison Tests Endocrinology 06/30/2006
Taidoc Technology easy check TD-4209 Blood Glucose Monitoring System   
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2006
Tyson Bioresearch, Inc. EZ-Smart-168 Blood Glucose Monitoring System  
K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Mizuho USA Multi-Use Electronic Pregnancy Test  
K060825 Urine hCG By Visual Color Comparison Tests Endocrinology 06/20/2006
Diagnostic Test Group, Clarity Blood Glucose Monitoring System  
K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/15/2006
HealthPia America Corporation, GlucoPack Blood Glucose Monitoring System  
K052469 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/15/2006
Immunostics, Inc., hema-screen SPECIFIC Immunochemical Fecal Occult Blood Test  
K060463 Fecal Occult Blood General Chemistry 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Amphetamines Toxicology / TDM 06/15/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Cannabinoids (THC) Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Phencyclidine (PCP) Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Cocaine Metabolites Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Opiates Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Methamphetamines Toxicology / TDM 06/15/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Amphetamines Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Cannabinoids (THC) Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Phencyclidine (PCP) Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Cocaine Metabolites Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Opiates Toxicology / TDM 06/15/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Methamphetamines Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/15/2006
Taidoc Clever Chek TD-3250 Blood Glucose Plus Blood Pressure Monitoring System  
K061073 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/06/2006
Inverness Medical, Inc. Clearblue Easy Digital Pregnancy Test  
K060128 Urine hCG By Visual Color Comparison Tests Endocrinology 06/01/2006
Kareway Product Pure-Aid Pregnancy Test  
K053452 Urine hCG By Visual Color Comparison Tests Endocrinology 05/31/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Meridian Bioscience Immunocard STAT! HpSA  (Stool)
K032222 Helicobacter Pylori Bacteriology 05/31/2006
BTNX Inc. Rapid Response One Step hCG Pregnancy Urine Test Cassette  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 05/22/2006
BTNX Inc. Rapid Response One Step hCG Pregnancy Urine Test Strip  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 05/22/2006
BTNX Inc. Rapid Response One Step hCG Pregnancy Urine/Serum Combo Cassette Test  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 05/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Blood Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 05/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick pH Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Protein Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 2 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 05/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest URS 2 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Protein Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Protein Urinalysis 05/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LifeScan OneTouch UltraMini Blood Glucose Monitoring System  
K061118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/22/2006
Progressive Health Supply and Source Smartest Protege Blood Glucose Monitoring System  
K032029 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/22/2006
CEN-MED Elite Plus hCG One Step Pregnancy Test Device (Urine/Serum)  
K981165 Urine hCG By Visual Color Comparison Tests Endocrinology 05/15/2006
Abbott Diabetes Care Inc. Optium Blood Glucose Monitoring System  
K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Amphetamines Toxicology / TDM 05/01/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Cannabinoids (THC) Toxicology / TDM 05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Phencyclidine (PCP) Toxicology / TDM 05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Cocaine Metabolites Toxicology / TDM 05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Propoxyphene Toxicology / TDM 05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Benzodiazepines Toxicology / TDM 05/01/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Barbiturates Toxicology / TDM 05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Morphine Toxicology / TDM 05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Tricyclic Antidepressants Toxicology / TDM 05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device  
K041685 Oxycodone Toxicology / TDM 05/01/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Amphetamines Toxicology / TDM 05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Cannabinoids (THC) Toxicology / TDM 05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Phencyclidine (PCP) Toxicology / TDM 05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Cocaine Metabolites Toxicology / TDM 05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Propoxyphene Toxicology / TDM 05/01/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Benzodiazepines Toxicology / TDM 05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Barbiturates Toxicology / TDM 05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Morphine Toxicology / TDM 05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Tricyclic Antidepressants Toxicology / TDM 05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/01/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories Tri-Fect Drug Screen Test Device  
K041743 Oxycodone Toxicology / TDM 05/01/2006
First Check Diagnostics LLC, First Check Home Drug Test Marijuana  
K050936 Cannabinoids (THC) Toxicology / TDM 05/01/2006
Solartek Products, Inc. Kroger Blood Glucose Monitoring System  
K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006
Solartek Products, Inc. ReliOn Ultima Blood Glucose Monitoring System  
K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006
Solartek Products, Inc. RiteAid Blood Glucose Monitoring System  
K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens)
K053126 Influenza A/B Virology 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Blood Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 04/19/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick pH Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Protein Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 04/19/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Amphetamines Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Cocaine Metabolites Toxicology / TDM 04/19/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Noble Medical Inc. Split-Specimen Cup  
K050878 Opiates Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Methamphetamines Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 04/19/2006
US Diagnostics, Inc. G4 Blood Glucose Monitoring System  
K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/19/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Ketone Urinalysis 04/11/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Bilirubin Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Blood Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Glucose Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Nitrite Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick pH Urinalysis 04/11/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Protein Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Specific Gravity Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   
K052525 Urine Qualitative Dipstick Leukocytes Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   
K052525 Urine Qualitative Dipstick Urobilinogen Urinalysis 04/11/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Polymer Technology Systems CardioChek Analyzer {PTS PANELS HDL Cholesterol Test Strips} 
K060617 HDL Cholesterol General Chemistry 04/10/2006
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS HDL Cholesterol Test Strips} 
K060617 HDL Cholesterol General Chemistry 04/10/2006
Hypoguard Assure Pro Blood Glucose Monitoring System  
K053079 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2006
Rapid Pathogen Screening RPS Adeno Detector  
K052092 Adenovirus Virology 03/30/2006
immoCARE Fecal Occult Blood Test  
K052598 Fecal Occult Blood General Chemistry 03/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott Freestyle Feedom Blood Glucose Monitoring System  
K051839 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006
Johnson & Johnson, Lifescan, Inc. One Touch Basic Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip} 
K052207 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006
Johnson & Johnson, Lifescan, Inc. One Touch II Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip} 
K052207 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006
Johnson & Johnson, Lifescan, Inc. One Touch Profile Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip} 
K052207 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 03/13/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Blood Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 03/13/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick pH Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Protein Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 03/13/2006
Bioptik Technology, Inc. EasyMate Blood Glucose Monitoring System  
K053312 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Ani Biotech Oy MySet Pregnancy Test  
K053138 hCG, Urine Endocrinology 03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device  
K050050 Amphetamines Toxicology / TDM 03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device  
K050050 Cannabinoids (THC) Toxicology / TDM 03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device  
K050050 Phencyclidine (PCP) Toxicology / TDM 03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device  
K050050 Cocaine Metabolites Toxicology / TDM 03/03/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device  
K050050 Opiates Toxicology / TDM 03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device  
K050050 Methamphetamines Toxicology / TDM 03/03/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup  
K050878 Amphetamines Toxicology / TDM 02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 02/27/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup  
K050878 Cocaine Metabolites Toxicology / TDM 02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup  
K050878 Opiates Toxicology / TDM 02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup  
K050878 Methamphetamines Toxicology / TDM 02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup  
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/27/2006
Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Cassette  
K060019 hCG, Urine Endocrinology 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Midstream  
K060019 hCG, Urine Endocrinology 02/22/2006
Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Strip  
K060019 hCG, Urine Endocrinology 02/22/2006
Artron One-Step Pregnancy Test  
K060019 hCG, Urine Endocrinology 02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Amphetamines Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Cannabinoids (THC) Toxicology / TDM 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
First Check Diagnostics First Check 12 Drug Test  
K052115 Phencyclidine (PCP) Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Cocaine Metabolites Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Opiates Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Methadone Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Methamphetamines Toxicology / TDM 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
First Check Diagnostics First Check 12 Drug Test  
K052115 Benzodiazepines Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Barbiturates Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Tricyclic Antidepressants Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Oxycodone Toxicology / TDM 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Genzyme Sure-Vue Signature MONO Test  (Whole blood)
K972231 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/22/2006
Germaine Laboratories AimStick 10-SG  
K051727 Urine Qualitative Dipstick Chemistries Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2GK  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-2GK  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2GpH  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2GpH  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2LN  
K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2LN  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-3  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-3  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-3  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-4  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4OB  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4OB  
K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4OB  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-4OB  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-5  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-5  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-5  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-5  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-5  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/22/2006
Germaine Laboratories AimStick US-B  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-BR  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Germaine Laboratories AimStick US-G  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-K  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-L  
K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006
Germaine Laboratories AimStick US-N  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Germaine Laboratories AimStick US-P  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-pH  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-SG  
K051727 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStick US-U  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006
ImmuLab, Inc. One Step Pregnancy Test Strip (Urine)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 02/22/2006
Instant Technologies Inc. One Step LH Ovulation Test Cassette  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/22/2006
Instant Technologies Inc. One Step LH Ovulation Test Strip  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/22/2006
Lifescan One Touch Ultra 2 Blood Glucose Monitoring System  
K053529 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/22/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
RAC Medical Clarity MONO Mononucleosis Rapid Test Device  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/22/2006
Saless Enterprises Inc. One Step LH Ovulation Test Cassette  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/22/2006
Axis-Shield Afinion AS100 Analyzer  
K050574 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 02/17/2006
Albertsons Equaline Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006
Chain Drug Consortium Premier Value Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/09/2006
McKesson SunMark Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006
Safeway Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006
AgaMatrix Liberty Blood Glucose Monitoring System  
K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/24/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
AgaMatrix Liberty Blood Glucose Monitoring System {professional use} 
K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Blood Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 01/24/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick pH Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Protein Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/24/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 01/24/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Amphetamines Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Cannabinoids (THC) Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Phencyclidine (PCP) Toxicology / TDM 01/17/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
First Check Diagnostics First Check Multi Drug Cup  
K051966 Cocaine Metabolites Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Opiates Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Methamphetamines Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/17/2006
Biotechnostix, Inc. Rapid Response FSH One Step Menopause Test Device  (professional use)
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 01/10/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
First Check Multi Drug Cup 12  (OTC)
K052115 Amphetamines Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Cannabinoids (THC) Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Phencyclidine (PCP) Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Cocaine Metabolites Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Opiates Toxicology / TDM 01/10/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
First Check Multi Drug Cup 12  (OTC)
K052115 Methadone Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Methamphetamines Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Benzodiazepines Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Barbiturates Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Tricyclic Antidepressants Toxicology / TDM 01/10/2006
Document Test System Name
Analyte		 Analyte Specialty Effective Date
First Check Multi Drug Cup 12  (OTC)
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Oxycodone Toxicology / TDM 01/10/2006
RAC Medical Clarity FSH One Step Menopause Test Device  (professional use)
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 01/10/2006
IND Diagnostic Inc. One Step HCG Pregnancy Test 2000 mIU/mL  
K052694 Urine hCG By Visual Color Comparison Tests Endocrinology 12/19/2005
Rapid Response Mononucleosis Rapid Test Device (whole blood)  
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 12/15/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Aventir Biotech, LLC Glucose Pilot Monitoring System  
K052208 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/12/2005
Sein Electronics Blood Glucose and Blood Pressure Measurement System, Model BGP-100  
K052108 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/08/2005
Runbio Biotech Co., Ltd. David Ovulation Test  
K053239 Ovulation Test (LH) By Visual Color Comparison Endocrinology 12/07/2005
Runbio Biotech Co., Ltd. David Ovulation Test  
K053238 Ovulation Test (LH) By Visual Color Comparison Endocrinology 12/06/2005
IND Diagnostic INC. One Step FSH Menopausal Test (Cassette)  
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic INC. One Step FSH Menopausal Test (midstream)  
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic INC. One Step FSH Menopausal Test (Strip)  
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic, Inc. One Step Cassette Style FSH Menopausal Test  (professional use)
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic, Inc. One Step Strip Style FSH Menopausal Test  (professional use)
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
Target Corporation EasyPRO Blood Glucose Mornitoring System  
K031388 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/02/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BioJENC Uro-nDip UTI Urinalysis Reagent Strip  
X050011 Urine Qualitative Dipstick Nitrite Urinalysis 11/29/2005
BioJENC Uro-nDip UTI Urinalysis Reagent Strip  
X050011 Urine Qualitative Dipstick pH Urinalysis 11/29/2005
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 11/29/2005
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick Blood Urinalysis 11/29/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 11/29/2005
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 11/29/2005
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick pH Urinalysis 11/29/2005
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/29/2005
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/29/2005
Henry Schein Urispec 11-Way Reagent Strip  
K991927 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-1 Parameter Glucose  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-1 Parameter Ketone  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Ketone  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Ketone  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Protein  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Protein  
K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein  
K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 11/29/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes  
K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood  
K993850 Urine Qualitative Dipstick Blood Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood  
K993850 Urine Qualitative Dipstick pH Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood  
K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone  
K993850 Urine Qualitative Dipstick Blood Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone  
K993850 Urine Qualitative Dipstick pH Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone  
K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Amphetamines Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Cannabinoids (THC) Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Phencyclidine (PCP) Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Cocaine Metabolites Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Opiates Toxicology / TDM 11/29/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Methamphetamines Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/29/2005
SA Scientific SAS Influenza A Test  
K041441 Influenza A Virology 11/23/2005
SA Scientific SAS Influenza B Test  
K041439 Influenza B Virology 11/23/2005
QuickVue iFOB Test (Immunochemical Fecal Occult Blood)  (cassette)
K021423 Fecal Occult Blood General Chemistry 11/09/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Target Corporation EasyPRO Blood Glucose Mornitoring System  
K020232 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/09/2005
CAREONE Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2005
Fisher Scientific Sure-Vue RSV Test  
K022845 Respiratory Syncytial Virus Virology 10/20/2005
Home Diagnostics Inc. Diabetes Centers of America TrueTrack Smart System Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2005
Meridian Bioscience ImmunoCard STAT! RSV PLUS  
K041445 Respiratory Syncytial Virus Virology 10/20/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Remel Xpect Rsv  
K022845 Respiratory Syncytial Virus Virology 10/20/2005
SA Scientific SAS RSV Test  
K022845 Respiratory Syncytial Virus Virology 10/20/2005
SA Scientific SAS RSVAlert  
K022845 Respiratory Syncytial Virus Virology 10/20/2005
Care Fecal Occult Blood Test  
K051806 Fecal Occult Blood General Chemistry 10/07/2005
Hypoguard Assure Pro Blood Glucose Monitoring System  
K051514 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/07/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Instant Technologies iScreen Mononucleosis Rapid Test Device  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/07/2005
Instant Technologies iScreen Mononucleosis Rapid Test Strip  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/07/2005
Taidoc Prodigy Blood Glucose Monitoring System  
K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/07/2005
Hemocue Glucose 201 DM Analyzer  
K041230 Glucose General Chemistry 09/28/2005
Instant Technologies iScreen H. pylori Rapid Test Device  
K024350 Helicobacter Pylori Antibodies General Immunology 09/27/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips} 
K023558 HDL Cholesterol General Chemistry 09/27/2005
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips} 
K023558 Cholesterol General Chemistry 09/27/2005
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips} 
K023558 HDL Cholesterol General Chemistry 09/27/2005
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips} 
K023558 Cholesterol General Chemistry 09/27/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (professional use)
K050878 Amphetamines Toxicology / TDM 09/13/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (professional use)
K050878 Cannabinoids (THC) Toxicology / TDM 09/13/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (professional use)
K050878 Phencyclidine (PCP) Toxicology / TDM 09/13/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (professional use)
K050878 Cocaine Metabolites Toxicology / TDM 09/13/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (professional use)
K050878 Opiates Toxicology / TDM 09/13/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (professional use)
K050878 Methamphetamines Toxicology / TDM 09/13/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (professional use)
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/13/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Blood Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 09/12/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick pH Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Protein Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/12/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/12/2005
CVS Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005
Good Neighbor Pharmacy Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 09/09/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Blood Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick pH Urinalysis 09/09/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Protein Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/09/2005
Leader Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005
Walgreens Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Roche Diagnostics Accu-Chek Go Blood Glucose Monitoring System  
K051592 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/08/2005
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Ketone Urinalysis 09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Bilirubin Urinalysis 09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Blood Urinalysis 09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Glucose Urinalysis 09/07/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Leukocytes Urinalysis 09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Nitrite Urinalysis 09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick pH Urinalysis 09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Protein Urinalysis 09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/07/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Creatinine Urinalysis 09/07/2005
accutest Multi-Drug, Multi-Line Screen Device  
K050050 Amphetamines Toxicology / TDM 09/01/2005
accutest Multi-Drug, Multi-Line Screen Device  
K050050 Cannabinoids (THC) Toxicology / TDM 09/01/2005
accutest Multi-Drug, Multi-Line Screen Device  
K050050 Phencyclidine (PCP) Toxicology / TDM 09/01/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
accutest Multi-Drug, Multi-Line Screen Device  
K050050 Cocaine Metabolites Toxicology / TDM 09/01/2005
accutest Multi-Drug, Multi-Line Screen Device  
K050050 Opiates Toxicology / TDM 09/01/2005
accutest Multi-Drug, Multi-Line Screen Device  
K050050 Methamphetamines Toxicology / TDM 09/01/2005
ACON Mononucleosis Rapid Test Device  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 09/01/2005
ACON Mononucleosis Rapid Test Strip  (Whole blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 09/01/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
RediScreen Multi-Drug, Multi-Line Screen Test Device  
K050050 Amphetamines Toxicology / TDM 09/01/2005
RediScreen Multi-Drug, Multi-Line Screen Test Device  
K050050 Cannabinoids (THC) Toxicology / TDM 09/01/2005
RediScreen Multi-Drug, Multi-Line Screen Test Device  
K050050 Phencyclidine (PCP) Toxicology / TDM 09/01/2005
RediScreen Multi-Drug, Multi-Line Screen Test Device  
K050050 Cocaine Metabolites Toxicology / TDM 09/01/2005
RediScreen Multi-Drug, Multi-Line Screen Test Device  
K050050 Opiates Toxicology / TDM 09/01/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
RediScreen Multi-Drug, Multi-Line Screen Test Device  
K050050 Methamphetamines Toxicology / TDM 09/01/2005
Biosite Triage Meter  (Whole blood)
K021317 B-Type Natriuretic Peptide (BNP) General Chemistry 08/26/2005
Biosite Triage Meter Plus  (Whole blood)
K021317 B-Type Natriuretic Peptide (BNP) General Chemistry 08/26/2005
Acon Laboratories, Inc. FSH One Step Menopause Test Device  (professional use)
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 08/24/2005
Acon Laboratories, Inc. FSH One Step Menopause Test Strip  (professional use)
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 08/24/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Roche Diagnostics AccuChek Instant Plus Dual Testing System  
K051376 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/24/2005
Roche Diagnostics AccuChek Instant Plus Dual Testing System  
K051376 Cholesterol General Chemistry 08/24/2005
Brooks Pharmacy Sidekick Blood Glucose Test System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005
Eckerd Pharmacy Sidekick Blood Glucose Test System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005
McKesson SunMark Performance Plus Sidekick Blood Glucose Test System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Medicine Shoppe Sidekick Blood Glucose Test System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005
Meijer Sidekick Blood Glucose Test System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005
WH Accu Test One-Step Urine/Serum Pregnancy Test  
K051841 Urine hCG By Visual Color Comparison Tests Endocrinology 08/22/2005
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 08/16/2005
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K942782 Glucose General Chemistry 08/16/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 08/16/2005
Abbott Freestyle Connect Blood Glucose Monitoring System  
K051802 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005
BIOMEDIX INC. Q STEPS Biometer G/C Dual Monitoring System  
K050182 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005
BIOMEDIX INC. Q STEPS Biometer G/C Dual Monitoring System  
K050182 Cholesterol General Chemistry 08/11/2005
Taidoc Clever Chek TD-3215 Blood Glucose and Blood Pressure Measurement System  
K051936 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Taidoc Dr. T TD-3216 Blood Glucose and Blood Pressure Measurement System  
K051936 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005
Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System {Home Use} 
K051285 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2005
Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System {professional use} 
K051285 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2005
Taidoc Clever Chek Blood Glucose Monitoring System TD-4225  
K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2005
McKesson Corporation Medi-Lab Performance hCG Urine - Cassette  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 08/01/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Mizuho USA Proof Positive  
K000844 Urine hCG By Visual Color Comparison Tests Endocrinology 08/01/2005
Wampole Laboratories Clearview hCG II  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 08/01/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Amphetamines Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Cannabinoids (THC) Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Phencyclidine (PCP) Toxicology / TDM 07/19/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Cocaine Metabolites Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Opiates Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Methadone Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Methamphetamines Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Benzodiazepines Toxicology / TDM 07/19/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Barbiturates Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Oxycodone Toxicology / TDM 07/19/2005
3test Blood Glucose Monitoirng System  
K050224 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/14/2005
Home Diagnostics Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/14/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole blood)
K042443 Triglyceride General Chemistry 07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole blood)
K042443 HDL Cholesterol General Chemistry 07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole blood)
K042443 Cholesterol General Chemistry 07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole blood)
K040332 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole blood)
K040332 Glucose General Chemistry 07/12/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Perrigo Company +/- Pregnancy Test  
K050546 Urine hCG By Visual Color Comparison Tests Endocrinology 07/12/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Amphetamines Toxicology / TDM 07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Cannabinoids (THC) Toxicology / TDM 07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Phencyclidine (PCP) Toxicology / TDM 07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Cocaine Metabolites Toxicology / TDM 07/08/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Opiates Toxicology / TDM 07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Methamphetamines Toxicology / TDM 07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Amphetamines Toxicology / TDM 07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Cannabinoids (THC) Toxicology / TDM 07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Phencyclidine (PCP) Toxicology / TDM 07/08/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Cocaine Metabolites Toxicology / TDM 07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Opiates Toxicology / TDM 07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Methamphetamines Toxicology / TDM 07/08/2005
Acon Laboratories, Inc. On Call Home Drug Test for Marijuana  
K050936 Cannabinoids (THC) Toxicology / TDM 06/30/2005
Acon Laboratories, Inc. On Call Home Drug Test for Marijuana and Cocaine  
K050936 Cannabinoids (THC) Toxicology / TDM 06/30/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories, Inc. On Call Home Drug Test for Marijuana and Cocaine  
K050936 Cocaine Metabolites Toxicology / TDM 06/30/2005
TheraSense FreeStyle 600 Blood Glucose Monitoring System  
K050500 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2005
Metrika INViEW MULTI-TEST A1C MONITOR  (For OTC use)
K051321 Glycated Hemoglobin, Total General Chemistry 06/15/2005
Metrika INViEW MULTI-TEST A1C MONITOR  (For professional use)
K051321 Glycated Hemoglobin, Total General Chemistry 06/15/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Amphetamines Toxicology / TDM 06/10/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Cocaine Metabolites Toxicology / TDM 06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Opiates Toxicology / TDM 06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Methamphetamine/Amphetamine Toxicology / TDM 06/10/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Bioscreen Medical One Step Cassette Style hCG Urine (Home) Pregnancy Test  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine Test Cassette  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine Test Strip  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine/Serum Test Cassette  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine/Serum Test Strip  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Bioscreen Medical One Step Midstream Style hCG Urine (Home) Pregnancy Test  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step Strip Style hCG Urine (Home) Pregnancy Test  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Wampole Laboratories Clearview hCG Combo  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Wampole Laboratories Clearview hCG Combo with Reference Line  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (professional use)
K050050 Amphetamines Toxicology / TDM 06/03/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (professional use)
K050050 Cannabinoids (THC) Toxicology / TDM 06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (professional use)
K050050 Phencyclidine (PCP) Toxicology / TDM 06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (professional use)
K050050 Cocaine Metabolites Toxicology / TDM 06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (professional use)
K050050 Opiates Toxicology / TDM 06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (professional use)
K050050 Methamphetamines Toxicology / TDM 06/03/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Home Diagnostics, Aurora Pharmacy TrueTrack Smart System Blood Glucose System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2005
Home Diagnostics, Closer Care TrueTrack Smart System Blood Glucose System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2005
LifesScan OneTouch InDuo Blood Glucose Monitoring System  
K043197 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2005
LifesScan OneTouch Ultra Blood Glucose Monitoring System  
K043197 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2005
LifesScan OneTouch UltrasSmart Blood Glucose Monitoring System  
K043197 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
McKesson Corporation Medi-Lab Performance hCG Combo - Cassette  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 06/03/2005
McKesson Corporation Medi-Lab Performance hCG Urine - Dipstick  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 06/03/2005
VIP Diagnostics LLC EZ Smart Blood Glucose Monitoring System  
K043340 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2005
Wampole Laboratories Clearview hCG II (Dipstick)  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 06/03/2005
Acon +/- Pregnancy Test  
K050546 hCG, Urine Endocrinology 05/23/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Pfizer e.p.t Certainty Pregnancy Test  
K050930 Urine hCG By Visual Color Comparison Tests Endocrinology 05/19/2005
Wampole Laboratories Clearview LH Ovulation Test  
K924903 Ovulation Test (LH) By Visual Color Comparison Endocrinology 05/18/2005
IND Diagnostic One Step hCG Pregnancy Test - Cassette Format  
K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 05/12/2005
Roche Diagnostics Accu-Chek Integra Blood Glucose Monitoring System  
K050872 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/05/2005
ROCHE DIAGNOSTICS CORP. ACCU-CHEK Aviva System  
K043474 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/02/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
RAC Medical Clarity HCG Combo Cassettes  
K974009 Urine hCG By Visual Color Comparison Tests Endocrinology 04/28/2005
RAC Medical Clarity HCG Urine Cassettes  
K023638 Urine hCG By Visual Color Comparison Tests Endocrinology 04/28/2005
RAC Medical Clarity Ketone Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 04/28/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick Blood Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick pH Urinalysis 04/28/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick Protein Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek US-4 OB  
K993850 Urine Qualitative Dipstick Blood Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek US-4 OB  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 04/28/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
RAC Medical Clarity Multistrip Urochek US-4 OB  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 04/28/2005
RAC Medical Clarity Multistrip Urochek US-4 OB  
K993850 Urine Qualitative Dipstick Protein Urinalysis 04/28/2005
EPS Bio Technology Easy Pain Supreme Blood Glucose Monitoring System  
K043245 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/27/2005
RAC Medical Clarity Multistrip Urochek US-2 GP Reactive Strip For Urine Detection of 2 Parameters  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 04/27/2005
RAC Medical Clarity Multistrip Urochek US-2 GP Reactive Strip For Urine Detection of 2 Parameters  
K993850 Urine Qualitative Dipstick Protein Urinalysis 04/27/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Mizuho USA Proof Positive Electronic Pregnancy Test  
K043231 Urine hCG By Visual Color Comparison Tests Endocrinology 04/26/2005
PerMaxim RadiScreen H. pylori Test Device  (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 04/26/2005
RAC Medical Clarity hCG Urine Strips  
K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 04/26/2005
ReliaLAB Inc. InstaRead Lithium System  (fingerstick or venipuncture whole blood)
K031579 Lithium Toxicology / TDM 04/22/2005
Biotechnostix Rapid Response Strep A Rapid Test Device  
K023766 Streptococcus, Group A Bacteriology 04/21/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Biotechnostix Rapid Response Strep A Rapid Test Strip  
K010582 Streptococcus, Group A Bacteriology 04/21/2005
RAC Medical Clarity Strep A Rapid Test Strips  
K010582 Streptococcus, Group A Bacteriology 04/21/2005
RAC Medical Clarity Strep A Twist Rapid Test Device  
K023766 Streptococcus, Group A Bacteriology 04/21/2005
US Diagnostics, Inc. EASYGLUCO Blood Monitoring System  
K043512 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/21/2005
US Diagnostics, Inc. Freedom Blood Glucose Monitoring System  
K043543 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/20/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Genzyme Corporation OSOM hCG Combo Test  
K043385 Urine hCG By Visual Color Comparison Tests Endocrinology 04/18/2005
Wampole Laboratories Clearview RSV  
K021789 Respiratory Syncytial Virus Virology 04/11/2005
Wondfo One Step HCG Urine Pregnancy Test  
K043443 Urine hCG By Visual Color Comparison Tests Endocrinology 04/08/2005
AFW Alliance Health Care America TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Albertson's Inc. Sav-On Osco By Albertson's TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
AmerisourceBergen Brite-Life TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
AmerisourceBergen Good Neighbor Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Brooks Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Cardinal Health Leader TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Cardinal Health Your 1st Choice For Value! TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Chain Drug Consortium, LLC Premier Value TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Clarity Hemosure One-Step Immunological Fecal Occult Blood Test  
K041202 Fecal Occult Blood General Chemistry 03/30/2005
CVS Pharmacy Inc. Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Eckerd Drug Company TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Family Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
H-E-B inControl Plus Complete Diabetes Monitoring Kit, TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Home Diagnostics Inc. Navarro TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Home Diagnostics, Inc. Discount Drug Mart Food Fair TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Home Diagnostics, TrackEASE Smart System Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Kmart Corp. American Fare TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Longs Drugs Glucose Monitor TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
McKesson Corporation SunMark Performance Plus Blood Glucose Monitoring System, TrueTrack Smart System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
McKesson Sunmark TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Medicine Shoppe International TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Meijer Distribution Inc. Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Preferred Plus Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Walgreens Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Winn-Dixie Stores Inc. (WD) TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 03/29/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Blood Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick pH Urinalysis 03/29/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Protein Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 03/29/2005
Polymer Technology Systems Cardiochek Brand Analyzer  
K040693 LDL Cholesterol General Chemistry 03/25/2005
Polymer Technology Systems CardioChek PA Analyzer  
K040693 LDL Cholesterol General Chemistry 03/25/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Accumetrics VerifyNow-Aspirin Assay  
K042423 Platelet Aggregation Hematology 03/22/2005
PerMaxim, RediScreen-Ultra Fecal Occult Blood Test  
K902360 Fecal Occult Blood General Chemistry 03/17/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Amphetamines Toxicology / TDM 03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Cannabinoids (THC) Toxicology / TDM 03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Phencyclidine (PCP) Toxicology / TDM 03/16/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Cocaine Metabolites Toxicology / TDM 03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Opiates Toxicology / TDM 03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Methamphetamines Toxicology / TDM 03/16/2005
GENZYME OSOM TRICHOMONAS RAPID TEST  
K033864 Trichomonas Parasitology 03/16/2005
Home Diagnostics Diabetics Experts Of America Blood Glucose System  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/16/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Home Diagnostics, Equaline TrueTrack Smart System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/16/2005
Home Diagnostics, Publix TrueTrack Smart System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/16/2005
Home Diagnostics, Safeway TrueTrack Smart System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/16/2005
Instant Technologies Inc. One Step hCG Pregnancy Urine Test Cassette  
K023638 Urine hCG By Visual Color Comparison Tests Endocrinology 03/16/2005
Instant Technologies, Inc. One Step hCG Pregnancy Urine Test Strip  
K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 03/16/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
McKesson Medi-Lab Performance Infectious Mononucleosis Test  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 03/16/2005
Saless Enterprises Inc. One Step hCG Pregnancy Urine Test Strip  
K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 03/16/2005
Saless Enterprises Inc. One Step hCG Pregnancy Urine Test Cassette  
K023638 Urine hCG By Visual Color Comparison Tests Endocrinology 03/16/2005
Hypoguard Advance Micro-Draw Blood Glucose Monitoring System  
K020232 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/10/2005
Howard Medical Company OneStep Pregnancy  
K980531 Urine hCG By Visual Color Comparison Tests Endocrinology 03/09/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Matrix Distributors, Inc. NexGen Blood Glucose Monitoring System  
K031388 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/09/2005
Inverness Medical, Clearview Mono-plus II  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 03/08/2005
MCKESSON MEDI-LAB PERFORMANCE STREP A TEST DIPSTICK  
K033855 Streptococcus, Group A Bacteriology 03/08/2005
Taidoc Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System  
K042795 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/08/2005
WAMPOLE LABORATORIES CLEARVIEW H. PYLORI II  (finger stick or whole blood)
K990892 Helicobacter Pylori Antibodies General Immunology 03/08/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Common Sense Ltd. VI-SENSE Acidity Test Kit  
K043109 Vaginal pH General Chemistry 03/07/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Ketone Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Bilirubin Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Blood Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Glucose Urinalysis 03/02/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Leukocytes Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Nitrite Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick pH Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Protein Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Urobilinogen Urinalysis 03/02/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Specific Gravity Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Ketone Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Bilirubin Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Blood Urinalysis 03/02/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Glucose Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Leukocytes Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Nitrite Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick pH Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Protein Urinalysis 03/02/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Urobilinogen Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Specific Gravity Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 03/02/2005
Access Bio Inc. CareStart PLUS Pregnancy Test  
K032159 hCG, Urine Endocrinology 02/28/2005
Access Bio Inc. CareStart Pregnancy Test  
K032159 hCG, Urine Endocrinology 02/28/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ALFA SCIENTIFIC DESIGNS - ISCREEN FECAL OCCULT BLOOD TEST  
K021423 Fecal Occult Blood General Chemistry 02/25/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Ketone Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Bilirubin Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Blood Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Glucose Urinalysis 02/18/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Leukocytes Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Nitrite Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick pH Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Protein Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/18/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/18/2005
DE Healthcare Products TruView hCG Pregnancy Test  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 02/18/2005
Henry Schein One Step+ hCG Strip Test  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 02/18/2005
Henry Schein One Step+ hCG Test  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine Qualitative Dipstick Ketone Urinalysis 02/18/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine Qualitative Dipstick Bilirubin Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine Qualitative Dipstick Blood Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine Qualitative Dipstick Glucose Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine Qualitative Dipstick Leukocytes Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine Qualitative Dipstick Nitrite Urinalysis 02/18/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine Qualitative Dipstick pH Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine Qualitative Dipstick Protein Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/18/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Amphetamines Toxicology / TDM 02/17/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Cannabinoids (THC) Toxicology / TDM 02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Phencyclidine (PCP) Toxicology / TDM 02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Cocaine Metabolites Toxicology / TDM 02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Opiates Toxicology / TDM 02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Methamphetamines Toxicology / TDM 02/17/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
DE Healthcare Products TruView hCG Combo Pregnancy Cassette Test  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 02/17/2005
DE Healthcare Products TruView hCG Pregnancy Cassette Test  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 02/17/2005
Henry Schein One Step+ hCG Combo Test  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 02/17/2005
VIP International Wholesalers, Corp. Ez Smart Blood Glucose Monitoring System  
K040848 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/17/2005
ACON SPECTRUM MIDSTREAM PREGNANCY TEST  
K042151 Urine hCG By Visual Color Comparison Tests Endocrinology 02/15/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS INVACARE QUALITY ALTERNATIVES BLOOD GLUCOSE MONITOR - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
HOME DIAGNOSTICS MCKESSON SUNMARK PERFORMANCE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
HOME DIAGNOSTICS MP TOTAL CARE BLOOD GLUCOSE TEST STRIPS - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
HOME DIAGNOSTICS NATIONAL RURAL ELECTRIC COOPERATIVE ASSOCIATION BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
HOME DIAGNOSTICS STAR MEDICAL BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Immunostics Immuno hCG Detector  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 02/15/2005
Immunostics Immuno hCG Detector Combi  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 02/15/2005
Immunostics Immuno hCG Detector Stix Test  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 02/15/2005
NEO DIAGNOSTICS INC. KETOCHECKS  
K033114 Urine Qualitative Dipstick Ketone Urinalysis 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)  
K041578 Amphetamines Toxicology / TDM 02/15/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH QUICKSCREEN (MODEL 9177X)  
K041578 Cannabinoids (THC) Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)  
K041578 Phencyclidine (PCP) Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)  
K041578 Cocaine Metabolites Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)  
K041578 Opiates Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)  
K041578 Amphetamines Toxicology / TDM 02/15/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH QUICKSCREEN (MODEL 9178X)  
K041578 Cannabinoids (THC) Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)  
K041578 Cocaine Metabolites Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)  
K041578 Opiates Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)  
K041578 Methamphetamines Toxicology / TDM 02/15/2005
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS CHOL+GLU TEST PANEL} 
K041750 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS CHOL+GLU TEST PANEL} 
K041750 Cholesterol General Chemistry 02/15/2005
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+GLU TEST PANEL} 
K041750 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+GLU TEST PANEL} 
K041750 Cholesterol General Chemistry 02/15/2005
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+GLU TEST PANEL} 
K041750 Cholesterol General Chemistry 02/15/2005
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+GLU TEST PANEL} (professional use)
K041750 Glucose General Chemistry 02/15/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
AZOG One Step hCG Home Pregnacy Test Device (Urine)  
K041748 Urine hCG By Visual Color Comparison Tests Endocrinology 02/14/2005
AZOG One Step hCG Home Pregnacy Test Strip (Urine)  
K041748 Urine hCG By Visual Color Comparison Tests Endocrinology 02/14/2005
AZOG One Step hCG Pregnacy Test Midstream (Urine)  
K041748 Urine hCG By Visual Color Comparison Tests Endocrinology 02/14/2005
BAYER RELI-ON KETONE TEST STRIPS  
K801270 Ketone, Urine General Chemistry 02/14/2005
Cardinal Health SP Brand Rapid Test hCG Cassette  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 02/04/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Cardinal Health SP Brand Rapid Test hCG Combo  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 02/04/2005
Cardinal Health SP Brand Rapid Test hCG Dipstick  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 02/04/2005
ALFA SCIENTIFIC DESIGNS INSTANT VIEW H. PYLORI WHOLE BLOOD RAPID TEST  
K024360 Helicobacter Pylori Antibodies General Immunology 02/01/2005
DIAGNOSTIC DEVICES INC. GLUCOCHECK BLOOD GLUCOSE MONITORING SYSTEM  
K032029 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/01/2005
Binax NOW RSV Test  
K032166 Respiratory Syncytial Virus Virology 01/28/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
INVERNESS MEDICAL SIGNIFY HCG CARD PREGNANCY TEST  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 01/27/2005
INVERNESS MEDICAL SIGNIFY HCG URINE/SERUM PREGNANCY TEST  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 01/27/2005
INVERNESS MEDICAL SIGNIFY HCG-URINE PREGNANCY TEST  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 01/27/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Amphetamines Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Cannabinoids (THC) Toxicology / TDM 01/26/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Phencyclidine (PCP) Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Cocaine Metabolites Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Opiates Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Methadone Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Methamphetamines Toxicology / TDM 01/26/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Benzodiazepines Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Barbiturates Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Tricyclic Antidepressants Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Oxycodone Toxicology / TDM 01/26/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Cardinal Health SP Brand Rapid Test Strep A Dipstick  
K033855 Streptococcus, Group A Bacteriology 01/25/2005
Beckman Coulter, ICON Mono  
X040027 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/24/2005
PRINCETON BIOMEDITECH STATUS FIRST STREP A  
K040708 Streptococcus, Group A Bacteriology 01/19/2005
Cardinal Health SP Brand Rapid Test H. Pylori  
K990892 Helicobacter Pylori Antibodies General Immunology 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Ketone Urinalysis 01/13/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Bilirubin Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Blood Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Glucose Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Leukocytes Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Nitrite Urinalysis 01/13/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick pH Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Protein Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/13/2005
Cardinal Health, SP Brand Rapid Test Mono  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/10/2005
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Inverness Medical, Signify Mono Test  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/10/2005
Inverness Medical, Signify Strep A Dipstick  
K033855 Streptococcus, Group A Bacteriology 01/10/2005
Bionime Corporation Rightest Blood Glucose Monitoring System  
K042678 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/06/2005
BAYER DIAGNOSTICS ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM  
K043158 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/29/2004
BAYER DIAGNOSTICS ASCENSIA ELITE DIABETES CARE SYSTEM  
K043311 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/29/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
DYNAMIC DIAGNOSTICS INC. ONEPLUS PREGNANCY  
K981165 Urine hCG By Visual Color Comparison Tests Endocrinology 12/29/2004
HOWARD MEDICAL COMPANY ONESTEP PLUS PREGNANCY  
K981165 Urine hCG By Visual Color Comparison Tests Endocrinology 12/29/2004
BIOSAFE LABORTORIES, INC., ANEMIAPRO SELF SCREENER  
K042379 Hemoglobin Hematology 12/22/2004
TAIDOC SWIFT CHEK BLOOD GLUCOSE MONITORING SYSTEM  
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/22/2004
GERMAINE LABORATORIES, AIMSTEP H. PYLORI  (Whole blood)
K024350 Helicobacter Pylori Antibodies General Immunology 12/09/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HENRY SCHEIN ONE STEP+ MONO TEST  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 12/09/2004
HOME DIAGNOSTICS, CAREONE TRUETRACK SMART SYSTEM  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
HOME DIAGNOSTICS, DUANE READE TRUE TRACK SMART SYSTEM  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
HOME DIAGNOSTICS, FASA BLOOD GLUCOSE MONITORING SYSTEM (PRESTIGE SMART SYSTEM IQ)  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
HOME DIAGNOSTICS, INVACARE TRUETRACK SMART SYSTEM  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS, MMM MEDICARE Y MUCHA MAS BLOOD GLUCOSE MONITORING SYSTEM (PRESTIGE SMART SYSTEM IQ)  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
HOME DIAGNOSTICS, MOLINA HEALTHCARE TRUETRACK SMART SYSTEM  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens)
K041049 Influenza A/B Virology 12/01/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Ketone Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Bilirubin Urinalysis 11/17/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Blood Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Glucose Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Leukocytes Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Nitrite Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick pH Urinalysis 11/17/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Protein Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 11/17/2004
PROVALIS DIAGNOSTICS IN2IT IN-OFFICE ANALYZER (II) A1C PRESCRIPTION HOME USE TEST SYSTEM  
K041635 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/09/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
TRINITY BIOTECH UNI-GOLD RECOMBIGEN HIV TEST  (Fingerstick, Venipuncture Whole Blood)
BP030025 HIV-1 Antibody General Immunology 11/05/2004
BECKMAN COULTER ICON DS STREP A  
K983386 Streptococcus, Group A Bacteriology 10/29/2004
BECKMAN COULTER, INC. ICON 20 HCG SERUM/URINE TEST  
K020439 Urine hCG By Visual Color Comparison Tests Endocrinology 10/29/2004
DE HEALTHCARE PRODUCTS TRUVIEW H. PYLORI TEST  
K990892 Helicobacter Pylori Antibodies General Immunology 10/29/2004
DE HEALTHCARE PRODUCTS TRUVIEW STREP A DIPSTICK TEST  
K033855 Streptococcus, Group A Bacteriology 10/29/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Henry Schein One Step+ Strep A Dipstick Test  
K033855 Streptococcus, Group A Bacteriology 10/29/2004
HENRY SCHEIN ONESTEP+ H. PYLORI TEST  
K990892 Helicobacter Pylori Antibodies General Immunology 10/29/2004
LABORATORY SUPPLY COMPANY (LSC) PEP STREP A CASSETTE TEST  
K023766 Streptococcus, Group A Bacteriology 10/29/2004
LABORATORY SUPPLY COMPANY (LSC) PEP STREP A DIPSTICK TEST  
K010582 Streptococcus, Group A Bacteriology 10/29/2004
STANBIO LABORATORY EZ-WELL STREP A RAPID DEVICE TEST  
K023766 Streptococcus, Group A Bacteriology 10/29/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CHURCH & DWIGHT CO., INC. FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST  
K040866 Urine hCG By Visual Color Comparison Tests Endocrinology 10/22/2004
CEN-MED Elite Plus One-Step Pregnancy Test (Urine Or Serum)  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 10/19/2004
APPLIED BIOTECH ONE STEP+ MONO TEST  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/15/2004
APPLIED BIOTECH TRUVIEW MONO TEST  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/15/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Ketone Urinalysis 09/27/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Bilirubin Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Blood Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Glucose Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Leukocytes Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Nitrite Urinalysis 09/27/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick pH Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Protein Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/27/2004
LABORATORY SUPPLY COMPANY (LSC) PEP HCG COMBO TEST  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 09/20/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LABORATORY SUPPLY COMPANY (LSC) PEP HCG STRIP TEST  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 09/20/2004
LABORATORY SUPPLY COMPANY (LSC) PEP HCG TEST  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 09/20/2004
Matrix Distributors, Inc. NexGen Blood Glucose Monitoring System  
K020232 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/20/2004
PEP PERFORMANCE ENHANCED PRODUCTS STREP A CASSETTE TEST  
K023766 Streptococcus, Group A Bacteriology 09/16/2004
PEP PERFORMANCE ENHANCED PRODUCTS STREP A DIPSTICK  
K010582 Streptococcus, Group A Bacteriology 09/16/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
UNIPATH DIAGNOSTICS FACT PLUS ONE-STEP PREGNANCY TEST  
K042280 Urine hCG By Visual Color Comparison Tests Endocrinology 09/14/2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE  
K041946 Urine hCG By Visual Color Comparison Tests Endocrinology 09/10/2004
TAIDOC ACHTUNG TD-4207 GLUCOSE TEST SYSTEM  
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/10/2004
TAIDOC CLEVER CHEK TD-4209 GLUCOSE TEST SYSTEM  
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/10/2004
TAIDOC CLEVER CHEK TD-4222 GLUCOSE TEST SYSTEM  
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/10/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST  
K041202 Fecal Occult Blood General Chemistry 09/08/2004
HYPOGUARD ADVANCE INTUITION BLOOD GLUCOSE MONITORING SYSTEM  
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/01/2004
HOME DIAGNOSTICS, TRACKEASE SMART SYSTEM BLOOD GLUCOSE METER  
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/27/2004
HYPOGUARD ADVANCE INTUITION BLOOD GLUCOSE MONITORING SYSTEM  
K011233 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/27/2004
Hypoguard Advance Micro-Draw Blood Glucose Monitoring System  
K031388 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/27/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BRISTOL-MYERS SQUIBB CO. CHOICE DM  
K033847 Glycated Hemoglobin, Total General Chemistry 08/26/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA (THC)  
K040327 Cannabinoids (THC) Toxicology / TDM 08/24/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA (THC) AND COCAINE (COC)  
K040327 Cannabinoids (THC) Toxicology / TDM 08/24/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA (THC) AND COCAINE (COC)  
K040327 Cocaine Metabolites Toxicology / TDM 08/24/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Amphetamines Toxicology / TDM 08/19/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Cannabinoids (THC) Toxicology / TDM 08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Phencyclidine (PCP) Toxicology / TDM 08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Cocaine Metabolites Toxicology / TDM 08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Opiates Toxicology / TDM 08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Methamphetamines Toxicology / TDM 08/19/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/19/2004
Clearview Ultra FOB Test  
K041297 Fecal Occult Blood General Chemistry 08/18/2004
Eumed Biotechnology Co. Eusure Blood Glucose Monitoring System  
K040678 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/18/2004
POLYMEDCO POLY STAT OC-LIGHT FOB TEST  
K041297 Fecal Occult Blood General Chemistry 08/18/2004
PROVALIS DIAGNOSTICS G5 II HBA1C TEST SYSTEM  
K041635 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 08/18/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
THYROTEC INC. THYROTEST WHOLE BLOOD TSH TEST  
K030912 Thyroid Stimulating Hormone (TSH) Endocrinology 08/18/2004
Apex Biotechnology Corporation {Hypoguard Assure 3 Blood Glucose Monitoring System} 
K011233 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/05/2004
Apex Biotechnology Corporation {Hypoguard Assure 3 Blood Glucose Monitoring System} 
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/29/2004
APPLIED BIOTECH SURESTEP EXACT STREP A TEST  
K033855 Streptococcus, Group A Bacteriology 07/26/2004
GENZYME OSOM ULTRA STREP A TEST  
K992658 Streptococcus, Group A Bacteriology 07/15/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole blood)
K023639 Triglyceride General Chemistry 07/09/2004
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole blood)
K023640 HDL Cholesterol General Chemistry 07/09/2004
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole blood)
K023642 Cholesterol General Chemistry 07/09/2004
HEMOCUE HB 201+SYSTEM  (CAPILLARY, VENOUS, ARTERIAL WHOLE BLOOD)
K032203 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 06/30/2004
ACON LABORATORIES, INC. FSH MENOPAUSE PREDICTOR TEST  
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 06/28/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BECKMAN COULTER HEMOCCULT ICT  
K961062 Fecal Occult Blood General Chemistry 06/28/2004
CHASMA SCIENTIFIC, INC., CHASMA-CULT {TRI-SLIDE AND SINGLE SLIDE STOOL} 
K761232 Fecal Occult Blood General Chemistry 06/28/2004
CHASMA SCIENTIFIC, INC., CHASMA-CULT {QUICK CULT SLIDE} 
K761232 Fecal Occult Blood General Chemistry 06/28/2004
HEMOCUE HB 201 DM ANALYZING SYSTEM  
K041234 Hemoglobin Hematology 06/28/2004
IMMUNOSTICS DETECTOR STREP A DIRECT  
K023766 Streptococcus, Group A Bacteriology 06/28/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
JANT PHARMACAL CORP CLINIPAK STREP A RAPID TEST STRIP  
K010582 Streptococcus, Group A Bacteriology 06/28/2004
UNIPATH DIAGNOSTICS CLEARBLUE EASY EASY READ PREGNANCY TEST  
K041404 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2004
ORASURE ORAQUICK ADVANCE RAPID HIV-1/2 ANTIBODY TEST  (ORAL FLUID, FINGERSTICK WHOLE BLOOD AND VENIPUNCTURE WHOLE BLOOD)
BP010047 HIV-1 and HIV-2 Antibodies General Immunology 06/25/2004
BECKMAN COULTER ICON II HCG  (urine/serum)
K860542 Urine hCG By Visual Color Comparison Tests Endocrinology 06/23/2004
TAIDOC CHECK GLUCOSE TEST SYSTEM  
K041107 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/23/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
TRINITY BIOTECH UNI-GOLD RECOMBIGEN HIV TEST  (WHOLE BLOOD (VENIPUNCTURE))
BP030025 HIV-1 Antibody General Immunology 06/23/2004
BECKMAN COULTER ICON II HCG (URINE)  
K865057 Urine hCG By Visual Color Comparison Tests Endocrinology 06/22/2004
CHOLESTECH L.D.X. {Whole blood} 
K032027 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 06/18/2004
Stanbio HemoPoint H2 Hemoglobin Measurement System  
K032482 Hemoglobin Hematology 06/09/2004
W.H.P.M. ONE-STEP PREGNANCY TEST  
K041273 Urine hCG By Visual Color Comparison Tests Endocrinology 06/08/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
TOTAL DIAGNOSTIC SALES, INC. TEST TIME HOME GLUCOSE TEST  
K943503 Glucose General Chemistry 06/07/2004
POLYMEDCO POLY STAT STREP A LIQUID TEST  
K021375 Streptococcus, Group A Bacteriology 06/04/2004
LIFESTREAM TECHNOLOGIES LIFESTREAM PLUS CHOLESTEROL MONITOR  
K033899 Cholesterol General Chemistry 06/02/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE  
K040629 Cannabinoids (THC) Toxicology / TDM 05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE  
K040629 Phencyclidine (PCP) Toxicology / TDM 05/26/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE  
K040629 Cocaine Metabolites Toxicology / TDM 05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE  
K040629 Opiates Toxicology / TDM 05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE  
K040629 Methamphetamines Toxicology / TDM 05/26/2004
ACCU-STAT HOME MULTI-DRUG TEST  
K040629 Amphetamines Toxicology / TDM 05/26/2004
BECKMAN COULTER HEMOCCULT ICT  
K961062 Fecal Occult Blood General Chemistry 05/26/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH MOMENTS MENOPAUSE CHECK  
K040575 Follicle Stimulating Hormone (FSH) Endocrinology 05/26/2004
Becton Dickinson, Paradigm Link Blood Glucose Monitor  
K040603 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/19/2004
APPLIED BIOTECH INSTACHECK FSH TEST  (professional use)
K023408 Follicle Stimulating Hormone (FSH) Endocrinology 05/11/2004
SYNOVA HEALTHCARE MENOCHECKPRO  (professional use)
K023408 Follicle Stimulating Hormone (FSH) Endocrinology 05/11/2004
HEMOCUE HEMOGLOBIN 201 + / HEMOCUE HEMOGLOBIN MICROCUVETTE SYSTEM  
K032203 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 05/04/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST  
K040008 Vaginal pH General Chemistry 05/03/2004
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST  
K040008 Amines General Chemistry 05/03/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST DEVICE (URINE)  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 04/27/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERUM)  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 04/27/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST STRIP (URINE)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 04/27/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM)  
K980736 Urine hCG By Visual Color Comparison Tests Endocrinology 04/27/2004
Roche Diagnostics Accu-Chek Go Blood Glucose Monitoring System  
K040796 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA (THC)  
K040327 Cannabinoids (THC) Toxicology / TDM 04/22/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA (THC) AND COCAINE (COC)  
K040327 Cannabinoids (THC) Toxicology / TDM 04/22/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA (THC) AND COCAINE (COC)  
K040327 Cocaine Metabolites Toxicology / TDM 04/22/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM  
K040814 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/15/2004
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM  
K040814 Ketone, Blood General Chemistry 04/15/2004
DE HEALTHCARE PRODUCTS TRUVIEW STREP A TEST  
K023766 Streptococcus, Group A Bacteriology 04/15/2004
AERSCHER HEMAPROMPT  
K031356 Gastric Occult Blood General Chemistry 04/07/2004
AERSCHER HEMAPROMPT FG  
K972763 Fecal Occult Blood General Chemistry 04/07/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACON ONE STEP OVULATION TEST DEVICE (URINE)  
X030003 Ovulation Test (LH) By Visual Color Comparison Endocrinology 04/05/2004
MEDISENSE PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM  
K040628 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2004
HOME DIAGNOSTICS, TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/25/2004
IND DIAGNOSTIC ONE STEP LH OVULATION TEST  
K040626 Ovulation Test (LH) By Visual Color Comparison Endocrinology 03/25/2004
Acon Helicobacter Pylori Rapid Test Device  
K024350 Helicobacter Pylori Bacteriology 03/23/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
UNIPATH DIAGNOSTICS CLEARBLUE EASY DIGITAL OVULATION TEST  
K040441 Ovulation Test (LH) By Visual Color Comparison Endocrinology 03/23/2004
UNIPATH DIAGNOSTICS CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST  
K040341 Urine hCG By Visual Color Comparison Tests Endocrinology 03/11/2004
PFIZER CONSUMER HEALTHCARE E.P.T. PREGNANCY TEST  
K040329 Urine hCG By Visual Color Comparison Tests Endocrinology 03/08/2004
HYPOGUARD DIASCREEN REAGENT STRIPS FOR URINALYSIS GLUCOSE/KETONES  (Over-The-Counter)
K033851 Urine Qualitative Dipstick Ketone Urinalysis 03/02/2004
HYPOGUARD DIASCREEN REAGENT STRIPS FOR URINALYSIS GLUCOSE/KETONES  (Over-The-Counter)
K033851 Urine Qualitative Dipstick Glucose Urinalysis 03/02/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Apex Biotechnology Corporation {HYPOGUARD ADVANCE INTUITION BLOOD GLUCOSE MONITORING SYSTEM} 
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD  
K023712 Cannabinoids (THC) Toxicology / TDM 02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD  
K023712 Phencyclidine (PCP) Toxicology / TDM 02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD  
K023712 Cocaine Metabolites Toxicology / TDM 02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD  
K023712 Opiates Toxicology / TDM 02/24/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD  
K023712 Methamphetamines Toxicology / TDM 02/24/2004
HEMOCARE  
K840527 Fecal Occult Blood General Chemistry 02/23/2004
SYNOVA HEALTHCARE MENOCHECK MENOPAUSE INDICATOR TEST  
K023408 Follicle Stimulating Hormone (FSH) Endocrinology 02/23/2004
HOME DIAGNOSTICS, BRITE-LIFE TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, BROOKS TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS, DISCOUNT DRUG MART FOOD FAIR TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, HEALTH CARE AMERICA TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, NAVARRO TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, PREFERRED PLUS PHARMACY TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, WINN DIXIE (WD) TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Quidel QuickVue Influenza A+B Test  
K031899 Influenza A Virology 02/06/2004
Quidel QuickVue Influenza A+B Test  
K031899 Influenza B Virology 02/06/2004
SA SCIENTIFIC SAS STREP A  (direct from throat swab)
K023270 Streptococcus, Group A Bacteriology 02/02/2004
PFIZER CONSUMER HEALTHCARE E.P.T. PREGNANCY TEST  
K033658 Urine hCG By Visual Color Comparison Tests Endocrinology 01/20/2004
ABBOTT MEDISENSE PRECISION XCEED DIABETES MONITORING SYSTEM  
K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/09/2004
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BT MEDICAL, BTG SMARTEST BLOOD GLUCOSE MONITORING SYSTEM  
K032029 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/08/2004
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine Qualitative Dipstick Blood Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 12/17/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine Qualitative Dipstick pH Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine Qualitative Dipstick Protein Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/17/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Blood Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 12/17/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick pH Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Protein Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/17/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Ketone Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Bilirubin Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Blood Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Glucose Urinalysis 12/17/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Leukocytes Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Nitrite Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick pH Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Protein Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/17/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/17/2003
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP  
K033041 Urine hCG By Visual Color Comparison Tests Endocrinology 12/11/2003
BIOTECH ATLANTIC INC UNIMARK ONE STEP HOME PREGNANCY TEST DEVICE  (cassette)
K032992 hCG, Urine Endocrinology 12/09/2003
STANDARD DIAGNOSTICS GOOD MORNING TEST  
K031798 Urine hCG By Visual Color Comparison Tests Endocrinology 12/09/2003
UNOTECH DIAGNOSTICS ACCUSTRIP HCG-COMBO MODEL, HCG-005  
K032987 hCG, Urine Endocrinology 12/09/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
UNOTECH DIAGNOSTICS ACCUTEST HCG-COMBO MODEL,HCG-004  
K032987 hCG, Urine Endocrinology 12/09/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Ketone Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Bilirubin Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Blood Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Glucose Urinalysis 12/05/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Leukocytes Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Nitrite Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick pH Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Protein Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/05/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/05/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Ketone Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Bilirubin Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Blood Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Glucose Urinalysis 11/25/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Leukocytes Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Nitrite Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick pH Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Protein Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/25/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/25/2003
HOME DIAGNOSTICS, AMERICAN FARE TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, ECKERD TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, FAMILY PHARMACY TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, GOOD NEIGHBOR PHARMACY TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS, HEB IN CONTROL PLUS BLOOD GLUCOSE SYSTEM, TRUETRACK SMART SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, MCKESSON SUNMARK PERFORMANCE PLUS BLOOD GLUCOSE SYSTEM, TRUETRACK SMART SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, PREMIER VALUE TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
Home Diagnostics, TrackEASE Smart System Blood Glucose Monitoring System, Truetrack Smart System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
CONCEPTION TECHNOLOGIES ASSURE LH OVULATION PREDICTOR  
K924903 Ovulation Test (LH) By Visual Color Comparison Endocrinology 11/06/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACON ONE STEP OVULATION TEST STRIP (URINE)  
X030004 Ovulation Test (LH) By Visual Color Comparison Endocrinology 11/05/2003
ACON QUIK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)  
K032661 Urine hCG By Visual Color Comparison Tests Endocrinology 11/05/2003
EKF DIAGNOSTIC HEMO_CONTROL MEASUREMENT AND HEMO_CONTROL MICROCUVETTES  
K031898 Hemoglobin Hematology 11/03/2003
AMERICAN HEALTHCARE EASYGLUCO BLOOD GLUCOSE TEST SYSTEM  
K031501 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/28/2003
GENOSIS FERTELL FEMALE FERTILITY TEST  
K032002 Follicle Stimulating Hormone (FSH) Endocrinology 10/21/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
GERMAINE LABORATORIES STREP AIM TOWER  
K023766 Streptococcus, Group A Bacteriology 10/21/2003
HMD BIOMEDICAL GLUCOLEADER ENHANCE BLOOD GLUCOSE MONITORING SYSTEM  
K032985 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/21/2003
ENTERIX INSURE FECAL IMMUNOCHEMICAL TEST  
K002457 Fecal Occult Blood General Chemistry 10/16/2003
UNIPATH EPT CERTAINTY PREGNANCY TEST  
K032939 Urine hCG By Visual Color Comparison Tests Endocrinology 10/15/2003
ORASURE TECHNOLOGIES ORAQUICK RAPID HIV-1 ANTIBODY TEST  (Fingerstick, Venipuncture Whole Blood)
BP010047 HIV-1 Antibody General Immunology 09/30/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CHDIAGNOSTICS SENOVA BLOOD GLUCOSE MONITORING SYSTEM  
K032076 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/29/2003
NEWTEK RELION BLOOD GLUCOSE MONITORING SYSTEM  
K024347 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/29/2003
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON SC STREP A TEST  
K023766 Streptococcus, Group A Bacteriology 09/25/2003
INSTANT TECHNOLOGIES ISTEP ONE STEP STREP A  
K023766 Streptococcus, Group A Bacteriology 09/25/2003
REDWOOD BIOTECH FECAL OCCULT BLOOD TEST  
K902360 Fecal Occult Blood General Chemistry 09/25/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST  
K032510 hCG, Urine Endocrinology 09/15/2003
ROCHE DIAGNOSTICS ACCU-CHEK ADVANTAGE III  
K032552 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/10/2003
QUIDEL QUICKVUE+ ONE-STEP HCG COMBO  
K973858 Urine hCG By Visual Color Comparison Tests Endocrinology 09/08/2003
INTEGRATED BIOTECHNOLOGY QUICK LAB RSV TEST  
K021789 Respiratory Syncytial Virus Virology 08/29/2003
Cardinal Health Leader TrueTrack Smart System, Blood Glucose Monitoring System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CVS Pharmacy Blood Glucose System, Truetrack Smart System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
Longs Drugs Truetrack Smart System, Blood Glucose Monitoring System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
SAV-ON OSCO BY ALBERTSON'S TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
The Medicine Shoppe Truetrack Smart System, Blood Glucose Monitoring System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
Walgreens Blood Glucose System, Truetrack Smart System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
YOUR 1ST CHOICE FOR VALUE! TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
Binax NOW RSV Test  
K021687 Respiratory Syncytial Virus Virology 08/21/2003
Beckman Coulter ICON SC Strep A test  
K023766 Streptococcus, Group A Bacteriology 08/08/2003
HMD BIOMEDICAL GLUCOLEADER VALUE GLUCOSE METER  
K023279 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/01/2003
PAN PROBE BIOTECH EARLYDETECT MENOPAUSE TEST FOR FSH  
K030058 Follicle Stimulating Hormone (FSH) Endocrinology 07/31/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
SACKS BIOLOGICALS AIMSTEP COMBO PREGNANCY  
K981165 Urine hCG By Visual Color Comparison Tests Endocrinology 07/31/2003
SACKS BIOLOGICALS AIMSTEP PREGNANCY  
K980531 Urine hCG By Visual Color Comparison Tests Endocrinology 07/31/2003
UNIPATH CLEARBLUE EASY OVULATION TEST  
K981271 Ovulation Test (LH) By Visual Color Comparison Endocrinology 07/31/2003
INSTANT TECHNOLOGIES IOVULATION MIDSTEAM OVULATION TEST  
K012252 Ovulation Test (LH) By Visual Color Comparison Endocrinology 07/11/2003
INSTANT TECHNOLOGIES IPREGNANCY HCG URINE PREGNANCY TEST  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 07/11/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
INSTANT TECHNOLOGIES IPREGNANCY HCG URINE/SERUM PREGRANCY TEST  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 07/11/2003
INSTANT TECHNOLOGIES IPREGNANCY PREGNANCY TEST STRIP (URINE)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 07/11/2003
PERMAXIM REDISCREEN MIDSTREAM URINE OVULATION TEST  
K012252 Ovulation Test (LH) By Visual Color Comparison Endocrinology 07/11/2003
PERMAXIM REDISCREEN MIDSTREAM URINE PREGNANCY TEST  
K983090 Urine hCG By Visual Color Comparison Tests Endocrinology 07/11/2003
PERMAXIM REDISCREEN PREGNANCY TEST STRIP (URINE)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 07/11/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PERMAXIM REDISCREEN URINE PREGNANCY CASSETTE DEVICE  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 07/11/2003
HOME DIAGNOSTICS, TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/10/2003
PERMAXIM REDISCREEN STREP A RAPID TEST  
K010582 Streptococcus, Group A Bacteriology 07/08/2003
SACKS MEDICAL REFUAH STREP A RAPID TEST  
K010582 Streptococcus, Group A Bacteriology 07/08/2003
INSTANT TECHNOLOGIES, ISTREP STREP A  
K010582 Streptococcus, Group A Bacteriology 07/03/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS ACCU-CHEK COMPACT TEST SYSTEM  
K031755 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2003
ACCESS BIO INC. CARESTART HCG COMBO ONE-STEP PREGNANCY TEST  
K031048 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2003
ACCESS BIO INC. CARESTART HCG ONE-STEP PREGNANCY TEST  
K031052 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2003
ACCESS BIO INC. CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST  
K031048 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2003
ACCESS BIO INC. CARESTART PLUS HCG ONE-STEP PREGNANCY TEST  
K031052 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
MAINLINE MAXIE HCG URINE PREGNANCY TEST  
K031445 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2003
MEDLINE INDUSTRIES EVENCARE BLOOD GLUCOSE MONITORING SYSTEM  
K031843 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/02/2003
APPLIED BIOTECH, INC. RU25 PLUS FSH MENOPAUSE TEST  
K023408 Follicle Stimulating Hormone (FSH) Endocrinology 06/24/2003
AMERISOURCE PHARMACAL ONE-STEP PREGNANCY TEST  
K031271 Urine hCG By Visual Color Comparison Tests Endocrinology 06/23/2003
ROCHE DIAGNOSTICS COAGUCHEK {PT-S TEST STRIPS} 
K021190 Prothrombin Time (PT) Hematology 06/18/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
SACKS MEDICAL CORPORATION REFUAH HCG-COMBO IMMUNOCHEMICAL TEST  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 06/17/2003
SACKS MEDICAL CORPORATION REFUAH HCG-URINE IMMUNOCHEMICAL TEST  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 06/17/2003
Acon Strep A Twist Rapid Test  
K023766 Streptococcus, Group A Bacteriology 06/12/2003
HOME DIAGNOSTICS MCKESSON SUNMARK BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/12/2003
TECO DIAGNOSTICS, URS-1P (PROTEIN TEST)  
K023172 Urine Qualitative Dipstick Protein Urinalysis 06/05/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ZER HITECH EASYCUP  
K023823 Urine hCG By Visual Color Comparison Tests Endocrinology 05/29/2003
BAYER ASCENSIA CONTOUR DIABETES CARE SYSTEM  
K023657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2003
ABBOTT MEDISENSE PRECISON XTRA/OPTIUM BLOOD GLUCOSE TEST STRIPS WITH TRUE MEASURE TECHNOLOGY  
K023256 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/23/2003
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM  
K031388 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/23/2003
INSTANT TECHNOLOGIES HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM)  
K980736 Urine hCG By Visual Color Comparison Tests Endocrinology 05/23/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
MEDLINE INDUSTRIES EVENCARE BLOOD GLUCOSE MONITORING SYSTEM  
K011240 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/23/2003
CHEMICON MONOHAEM  
K901064 Fecal Occult Blood General Chemistry 05/15/2003
TECO DIAGNOSTICS URS-1N (NITRITE TEST)  
K023325 Urine Qualitative Dipstick Nitrite Urinalysis 05/15/2003
TECO DIAGNOSTICS, URINE REAGENT STRIPS (URS-1B) TESTS FOR BLOOD  
K023297 Urine Qualitative Dipstick Blood Urinalysis 05/15/2003
HEMOCUE DONOR HEMOGLOBIN CHECKER SYSTEM  
BK030020 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 05/14/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
UNIPATH CLEARBLUE EASY DIGITAL PREGNANCY TEST {OTC} 
K030659 Urine hCG By Visual Color Comparison Tests Endocrinology 05/14/2003
BECKMAN COULTER ICON MICROALB  
K022538 Albumin, Urinary General Chemistry 05/13/2003
INSTANT TECHNOLOGIES IPREGNANCY MIDSTREAM PREGNANCY TEST  
K983090 Urine hCG By Visual Color Comparison Tests Endocrinology 05/12/2003
BINAX NOW FLU A TEST  
K021649 Influenza A Virology 05/08/2003
Binax NOW Flu B Test {Nashal Wash, Nasopharyngeal} 
K021646 Influenza B Virology 05/08/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ALIDEX, INC. POLY STAT SERUM/URINE HCG TEST  
K030430 Urine hCG By Visual Color Comparison Tests Endocrinology 05/01/2003
BAYER DIAGNOSTICS ASCENCIA BREEZE BLOOD GLUCOSE METER  
K024062 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2003
CENOGENICS ACCUNATE HOME PREGNANCY TEST  
K030533 Urine hCG By Visual Color Comparison Tests Endocrinology 05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447 Amphetamines Toxicology / TDM 05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447 Cannabinoids (THC) Toxicology / TDM 05/01/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447 Cocaine Metabolites Toxicology / TDM 05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447 Opiates Toxicology / TDM 05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447 Methamphetamine/Amphetamine Toxicology / TDM 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB  
K896454 Urine Qualitative Dipstick Blood Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB  
K896454 Urine Qualitative Dipstick Glucose Urinalysis 05/01/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB  
K896454 Urine Qualitative Dipstick Leukocytes Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB  
K896454 Urine Qualitative Dipstick Nitrite Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB  
K896454 Urine Qualitative Dipstick Protein Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Ketone Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Blood Urinalysis 05/01/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Glucose Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Leukocytes Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Nitrite Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick pH Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Protein Urinalysis 05/01/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
SA SCIENTIFIC SURE-VUE URINE HCG  
K010593 hCG, Urine Endocrinology 05/01/2003
WAMPOLE PREVUE HCG CASSETTE URINE OR SERUM  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 05/01/2003
ADC CLIA WAIVED MARIJUANA (THC) AND COCAINE TEST  
K003708 Cannabinoids (THC) Toxicology / TDM 04/30/2003
ADC CLIA WAIVED MARIJUANA (THC) AND COCAINE TEST  
K003708 Cocaine Metabolites Toxicology / TDM 04/30/2003
ADC CLIA WAIVED MARIJUANA (THC) TEST  
K001567 Cannabinoids (THC) Toxicology / TDM 04/29/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD  
K001126 Cannabinoids (THC) Toxicology / TDM 04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD  
K001126 Phencyclidine (PCP) Toxicology / TDM 04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD  
K001126 Cocaine Metabolites Toxicology / TDM 04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD  
K001126 Opiates Toxicology / TDM 04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD  
K001126 Methamphetamines Toxicology / TDM 04/29/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ADVANCED DIAGNOSTICS INC MIDSTREAM PREGNANCY TEST  
K023037 hCG, Urine Endocrinology 04/15/2003
GERMAINE LABORATORIES ACCUHOME OVULATION  
X030008 Ovulation Test (LH) By Visual Color Comparison Endocrinology 03/27/2003
GI SUPPLY, DIV. CHEK-MED SYSTEMS HP ONE  
K012411 Helicobacter Pylori Bacteriology 03/24/2003
ALATEX SCIENTIFIC PEACE OF MIND MARIJUANA (THC) AND COCAINE HOME DRUG TEST  
K011962 Cannabinoids (THC) Toxicology / TDM 03/17/2003
ALATEX SCIENTIFIC PEACE OF MIND MARIJUANA (THC) AND COCAINE HOME DRUG TEST  
K011962 Cocaine Metabolites Toxicology / TDM 03/17/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS DUANE READE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2003
GENZYME OSOM MONO TEST  
K972231 Infectious Mononucleosis Antibodies (Mono) General Immunology 03/06/2003
TECO DIAGNOSTICS, URINE REAGENT STRIPS (URS-1B) TESTS FOR BLOOD  
K023297 Urine Qualitative Dipstick Blood Urinalysis 03/06/2003
INVERNESS MEDICAL ACCUCLEAR EARLY PREGNANCY TEST  
K002049 Urine hCG By Visual Color Comparison Tests Endocrinology 03/05/2003
STANBIO QUSTICK STREP A  
K010582 Streptococcus, Group A Bacteriology 03/05/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
STANBIO TRUE 20 ONE-STEP PREGNANCY TEST  
K980531 Urine hCG By Visual Color Comparison Tests Endocrinology 03/05/2003
TECO DIAGNOSTICS URS-1N (NITRITE TEST)  
K023325 Urine Qualitative Dipstick Nitrite Urinalysis 02/28/2003
TECO DIAGNOSTICS, URS-1P (PROTEIN TEST)  
K023172 Urine Qualitative Dipstick Protein Urinalysis 02/28/2003
IND DIAGNOSTIC ONE STEP CASSETTE STYLE HCG URINE PREGNANCY TEST  
K023638 Urine hCG By Visual Color Comparison Tests Endocrinology 02/21/2003
GENZYME CONTRAST II HCG URINE/SERUM  
K023544 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IMMUNOSTICS IMMUNO/STREP A DETECTOR  
K010582 Streptococcus, Group A Bacteriology 02/13/2003
BAYER DIAGNOSTICS CLINITEST HCG PREGNANCY TEST  
K023944 Urine hCG By Visual Color Comparison Tests Endocrinology 02/12/2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM  
K023561 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 02/12/2003
AERSCHER HEMAPROMPT FG  
K972763 Gastric Occult Blood General Chemistry 02/11/2003
ABBOTT MEDISENSE {PRECISION XTRA COMPLETE} 
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/10/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ABBOTT MEDISENSE {OPTIUM COMPLETE} 
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/10/2003
LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM  
K024194 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/10/2003
LIFESCAN ONETOUCH IN DUO BLOOD GLUCOSE MONITORING SYSTEM  
K024194 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/10/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Ketone Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Bilirubin Urinalysis 02/06/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Blood Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Glucose Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Leukocytes Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Nitrite Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick pH Urinalysis 02/06/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Protein Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/06/2003
HERITAGE HOUSE '76, INC. PRECIOUS FEET PREGNANCY TEST  
K023638 Urine hCG By Visual Color Comparison Tests Endocrinology 02/06/2003
APPLIED BIOTECH DRUGFREE @HOME COCAINE TEST  
K022805 Cocaine Metabolites Toxicology / TDM 02/04/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
APPLIED BIOTECH DRUGFREE @HOME THC TEST  (OTC)
K022802 Cannabinoids (THC) Toxicology / TDM 02/04/2003
APPLIED BIOTECH INSTACHECK OVULATION TEST  (OTC)
K023295 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/04/2003
APPLIED BIOTECH MENOPAUSE PREDICTOR TEST  
K023408 Follicle Stimulating Hormone (FSH) Endocrinology 02/04/2003
ORASURE ORAQUICK RAPID HIV-1 TEST  
BP010047 HIV-1 Antibody General Immunology 01/31/2003
JANT PHARMACAL CLINIPAK  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 01/24/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
FOREFRONT DIAGNOSTICS INSTACHECK DRUG SCREEN THC  
K971959 Cannabinoids (THC) Toxicology / TDM 01/23/2003
FOREFRONT DIAGNOSTICS INSTACHECK MULTI-DRUG SCREEN PANEL  (THC/COC)
K993863 Cannabinoids (THC) Toxicology / TDM 01/23/2003
FOREFRONT DIAGNOSTICS INSTACHECK MULTI-DRUG SCREEN PANEL  (THC/COC)
K993863 Cocaine Metabolites Toxicology / TDM 01/23/2003
ABBOTT MEDISENSE PRECISION /OPTIMUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS WITH TRUE MEASURE TECHNOLOGY  
K021960 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/13/2003
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS HEMOCCULT II SENSA ELITE  
K880499 Fecal Occult Blood General Chemistry 01/13/2003
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BIO-RAD MICROMAT II HEMOGLOBIN A1C PRESCRIPTION HOME USE TEST  
K021935 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 12/17/2002
LIFESCAN SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM  
K023832 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2002
SA SCIENTIFIC SAS BLOOD/SERUM/URINE HCG  
K022683 Urine hCG By Visual Color Comparison Tests Endocrinology 12/17/2002
YD DIAGNOSTICS PREG-Q PREGNANCY TEST  
K023027 Urine hCG By Visual Color Comparison Tests Endocrinology 12/17/2002
ADVANTAGE DIAGNOSTICS ADVANTAGE THC TEST  
K001567 Cannabinoids (THC) Toxicology / TDM 12/09/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ADVANTAGE DIAGNOSTICS MULTI DOA TEST  
K001126 Cannabinoids (THC) Toxicology / TDM 12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST  
K001126 Phencyclidine (PCP) Toxicology / TDM 12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST  
K001126 Cocaine Metabolites Toxicology / TDM 12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST  
K001126 Opiates Toxicology / TDM 12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST  
K001126 Methamphetamines Toxicology / TDM 12/09/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME QUICK CUP PREGNANCY TEST  
K993141 Urine hCG By Visual Color Comparison Tests Endocrinology 12/09/2002
PHAMATECH CLEAR CHOICE PREGNANCY TEST  
K993141 Urine hCG By Visual Color Comparison Tests Endocrinology 12/09/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Ketone Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Bilirubin Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Blood Urinalysis 12/06/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Glucose Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Leukocytes Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Nitrite Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick pH Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Protein Urinalysis 12/06/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/06/2002
ADVANTAGE DIAGNOSTICS ADVANTAGE THC/COCAINE TEST  
K003708 Cannabinoids (THC) Toxicology / TDM 12/03/2002
ADVANTAGE DIAGNOSTICS ADVANTAGE THC/COCAINE TEST  
K003708 Cocaine Metabolites Toxicology / TDM 12/03/2002
HEMOSENSE INRATIO SYSTEM  
K020679 Prothrombin Time (PT) Hematology 12/03/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
UNIPATH CLEARBLUE EASY EARLY RESULT PREGNANCY TEST  
K023699 Urine hCG By Visual Color Comparison Tests Endocrinology 11/27/2002
AMEDITECH IMMUTEST HCG PREGNANCY TEST  
K023126 Urine hCG By Visual Color Comparison Tests Endocrinology 11/21/2002
LIFESCAN HARMONY INR MONITORING SYSTEM  (professional use)
K022922 Prothrombin Time (PT) Hematology 11/21/2002
LIFESCAN HARMONY INR MONITORY SYSTEM  (Prescription Home Use)
K022922 Prothrombin Time (PT) Hematology 11/21/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Triglyceride General Chemistry 11/21/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 HDL Cholesterol General Chemistry 11/21/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Cholesterol General Chemistry 11/21/2002
Polymer Technology Systems CardioChek Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Triglyceride General Chemistry 11/21/2002
Polymer Technology Systems CardioChek Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 HDL Cholesterol General Chemistry 11/21/2002
Polymer Technology Systems CardioChek Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Cholesterol General Chemistry 11/21/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Triglyceride General Chemistry 11/21/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 HDL Cholesterol General Chemistry 11/21/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Cholesterol General Chemistry 11/21/2002
PHAMATECH OVUCARD LH TEST  (cassette)
K990249 Ovulation Test (LH) By Visual Color Comparison Endocrinology 11/20/2002
PHAMATECH OVUSTICK LH TEST  (strip)
K990249 Ovulation Test (LH) By Visual Color Comparison Endocrinology 11/20/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
DE HEALTHCARE PRODUCTS TRU VIEW ONE-STEP PREGNANCY TEST  
K990578 Urine hCG By Visual Color Comparison Tests Endocrinology 11/19/2002
Metrika A1cNow For Home Use  
K022661 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/19/2002
SOLARTEK PRODUCTS, RITE AID BLOOD GLUCOSE MONITORING SYSTEM  
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/15/2002
Roche Diagnostics CoaguChek S System {PT-S TEST STRIPS} 
K020831 Prothrombin Time (PT) Hematology 11/14/2002
IMMUNOCARD STAT! HCG COMBO ADVANTAGE PREGNANCY TEST  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 11/13/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IND DIAGNOSTIC ONE STEP CASSETTE STYLE HCG SERUM/URINE COMBO TEST  
K974009 Urine hCG By Visual Color Comparison Tests Endocrinology 11/13/2002
ROCHE DIAGNOSTICS COAGUCHEK {PT-S TEST STRIPS} 
K021190 Prothrombin Time (PT) Hematology 11/12/2002
HOME DIAGNOSTICS MEDLINE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/08/2002
HOME DIAGNOSTICS SHOPRITE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/08/2002
ABBOTT MEDISENSE PCX BLOOD GLUCOSE TESTING SYSTEM  
K022941 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ABBOTT MEDISENSE PCX PLUS BLOOD GLUCOSE TEST STRIPS  
K022941 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2002
ALFA SCIENTIFIC DESIGNS INSTANT-VIEW LH OVULATION PREDICTING TEST  (cassette)
K022829 Ovulation Test (LH) By Visual Color Comparison Endocrinology 11/01/2002
AZOG INC HCG URINE ONE STEP URINE PREGNANCY TEST  (Dipstick)
K022680 Urine hCG By Visual Color Comparison Tests Endocrinology 11/01/2002
AZOG INC HCG URINE ONE STEP URINE PREGNANCY TEST  (cassette)
K022681 Urine hCG By Visual Color Comparison Tests Endocrinology 11/01/2002
LIFESCAN SURESTEP FLEXX BLOOD GLUCOSE MONITORING SYSTEM  
K023194 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LIFESCAN SURESTEP PRO  
K023194 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2002
DE HEALTHCARE PRODUCTS TRUVIEW STREP A TEST  
K992658 Streptococcus, Group A Bacteriology 10/23/2002
HENRY SCHEIN ONE STEP+ STREP A TEST  
K992658 Streptococcus, Group A Bacteriology 10/23/2002
GERMAINE LABORATORIES STREPAIM RAPID DIPSTICK TEST  
K010582 Streptococcus, Group A Bacteriology 10/21/2002
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM  
K982076 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/18/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 Triglyceride General Chemistry 10/18/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 HDL Cholesterol General Chemistry 10/18/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 Cholesterol General Chemistry 10/18/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 Triglyceride General Chemistry 10/18/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 HDL Cholesterol General Chemistry 10/18/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 Cholesterol General Chemistry 10/18/2002
SCITECK DIAGNOSTICS BABYCHECK ONE STEP PREGNANCY TEST  
K960174 Urine hCG By Visual Color Comparison Tests Endocrinology 10/18/2002
BECTON DICKINSON LATITUDE DIABETES MANAGEMENT SYSTEM  
K022580 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/08/2002
BECTON DICKINSON LOGIC GLUCOSE MONITOR  
K022581 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/08/2002
HYPOGUARD GLUCOBALANCE DATA MANAGEMENT SOFTWARE  
K022545 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/08/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
INTERNATIONAL NEWTECH DEVELOP. MINISTRIP HCG ONESTEP  
K974059 Urine hCG By Visual Color Comparison Tests Endocrinology 09/25/2002
PHAMATECH ONE-STEP OPIATE DRUG SCREENING TEST {cassette} 
K972619 Opiates Toxicology / TDM 09/20/2002
PHAMATECH QUICKSCREEN ONE-STEP OPIATE {DIP} 
K972619 Opiates Toxicology / TDM 09/20/2002
ABBOTT MEDISENSE RELION DIABETES CARE STARTER KIT  
K944195 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2002
HERITAGE HOUSE '76, INC. PRECIOUS FEET PREGNANCY TEST  
K980531 Urine hCG By Visual Color Comparison Tests Endocrinology 09/09/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LIFESCAN ONETOUCH SURESTEP BLOOD GLUCOSE MONITORING SYSTEM  
K022724 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2002
MEDISENSE OPTIUM EASY BLOOD GLUCOSE TESTING SYSTEM  
K022182 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/06/2002
MEDISENSE PRECISION EASY BLOOD GLUCOSE TESTING SYSTEM  
K022182 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/06/2002
BIOTEST HEMOGLOBIN MEASURING SYSTEM  
K020710 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 08/29/2002
DIAGNOSTIC CHEMICALS IMMUNODIP URINARY ALBUMIN TEST  
K022538 Albumin, Urinary General Chemistry 08/29/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS PRESTIGE IQ BLOOD GLUCOSE SYSTEM {CHAY MEDICAL 3 MICROLITER EXCELSIOR TEST STRIPS} 
K021781 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/29/2002
HOME DIAGNOSTICS PRESTIGE LX BLOOD GLUCOSE SYSTEM {CHAY MEDICAL 3 MICROLITER EXCELSIOR TEST STRIPS} 
K021781 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/29/2002
LIFESCAN ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM  
K021819 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Amphetamines Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Cannabinoids (THC) Toxicology / TDM 08/29/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Phencyclidine (PCP) Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Cocaine Metabolites Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Opiates Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Methamphetamines Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Amphetamines Toxicology / TDM 08/29/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Cannabinoids (THC) Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Phencyclidine (PCP) Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Cocaine Metabolites Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Opiates Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Methamphetamines Toxicology / TDM 08/29/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LUNA FERTILITY INDICATOR  
K020953 Fern Test, Saliva Endocrinology 08/26/2002
O2 UNLIMITED DONNA OVULATION TESTER  
K020811 Fern Test, Saliva Endocrinology 08/26/2002
PHAMATECH QUICKSCREEN PCP DRUG SCREENING TEST  (DIP)
K974582 Phencyclidine (PCP) Toxicology / TDM 08/26/2002
PHAMATECH QUICKSCREEN PCP DRUG SCREENING TEST  (cassette)
K974582 Phencyclidine (PCP) Toxicology / TDM 08/26/2002
STESANS MAYBE?MOM MINI OVULATION MICROSCOPE  
K013582 Fern Test, Saliva Endocrinology 08/26/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH QUICK SCREEN THC DRUG SCREENING TEST  (cassette)
K973122 Cannabinoids (THC) Toxicology / TDM 08/23/2002
PHAMATECH QUICK SCREEN THC DRUG SCREENING TEST  (DIP)
K973122 Cannabinoids (THC) Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN AMPHETAMINE DRUG SCREENING TEST  (cassette)
K972577 Amphetamines Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN AMPHETAMINE DRUG SCREENING TEST  (DIP)
K972577 Amphetamines Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN COCAINE DRUG SCREENING TEST  (cassette)
K972618 Cocaine Metabolites Toxicology / TDM 08/23/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH QUICKSCREEN COCAINE DRUG SCREENING TEST  (DIP)
K972618 Cocaine Metabolites Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN METHAMPHETAMINE DRUG SCREEN TEST  (cassette)
K972556 Methamphetamines Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN METHAMPHETAMINE DRUG SCREEN TEST  (DIP)
K972556 Methamphetamines Toxicology / TDM 08/23/2002
ALIDEX, INC. POLY STAT HCG DIPSTICK TEST  
K021386 Urine hCG By Visual Color Comparison Tests Endocrinology 08/20/2002
MATRITECH BLADDERCHEK  (Prescription Home Use)
K021231 Bladder Tumor Associated Antigen General Immunology 08/12/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
MATRITECH BLADDERCHEK  (professional use)
K021231 Bladder Tumor Associated Antigen General Immunology 08/12/2002
MERIDIAN BIOSCIENCE IMMUNOCARD STAT! H. PYLORI WHOLE BLOOD TEST  
K990892 Helicobacter Pylori Antibodies General Immunology 08/09/2002
SERIM PYLORITEK VP TEST KIT  
K014038 Helicobacter Pylori Bacteriology 07/25/2002
ROCHE DIAGNOSTICS ACCU-CHEK COMPACT TEST SYSTEM  
K022171 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/22/2002
GENZYME OSOM ULTRA STREP A TEST  (25 TEST KIT)
K992658 Streptococcus, Group A Bacteriology 07/19/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PAN PROBE BIOTECH LIVESURE HCG URINARY PREGNANCY TEST CARD  
K020968 Urine hCG By Visual Color Comparison Tests Endocrinology 07/15/2002
PAN PROBE BIOTECH LIVESURE HCG URINARY PREGNANCY TEST STRIP  
K020968 Urine hCG By Visual Color Comparison Tests Endocrinology 07/15/2002
HEMOCUE GLUCOSE 201 MICROCUVETTES AND GLUCOSE 201 ANALYZER WITH PLASMA CONVERSION  
K020935 Glucose General Chemistry 07/12/2002
Quidel QuickVue In-Line Strep A  
K934484 Streptococcus, Group A Bacteriology 07/08/2002
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM  
K021827 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/02/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CHOLESTECH GDX A1C TEST  (Prescription Home Use)
K011933 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 07/01/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS  
K990247 HDL Cholesterol General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS  
K990688 Cholesterol General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS  
K981493 Cholesterol General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS  
K993377 HDL Cholesterol General Chemistry 06/25/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Polymer Technology Systems CardioChek Analyzer  
K014099 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/25/2002
Polymer Technology Systems CardioChek PA Analyzer  
K014099 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS PTS GLUCOSE Q3  
K014099 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS PTS PANELS GLUCOSE TEST STRIPS  
K014099 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/25/2002
STANBIO QUPID PLUS E.R. ONE STEP PREGNANCY  
K020378 Urine hCG By Visual Color Comparison Tests Endocrinology 06/19/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Bayer Diagnostics Ascensia DEX 2 Diabetes Care System  
K963500 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/14/2002
BAYER DIAGNOSTICS GLUCODISC BLOOD GLUCOSE TEST STRIPS  
K012205 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/14/2002
QUIDEL OVUQUICK ONE-STEP OVULATION PREDICTOR  
K953063 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/13/2002
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST  
K962718 Vaginal pH General Chemistry 06/13/2002
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST  
K962718 Amines General Chemistry 06/13/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST  
K020869 Amphetamines Toxicology / TDM 06/13/2002
DE HEALTHCARE PRODUCTS HCG STRIP TEST  
K941090 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
HENRY SCHEIN ONESTEP + HCG STRIP TEST  
K941090 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
HENRY SCHEIN ONESTEP + HCG TEST  
K941090 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
IMMUNOSTICS IMMUNO DETECTOR COMBI  
K013194 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
IMMUNOSTICS IMMUNO DETECTOR PERSONAL  
K960174 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
WAMPOLE PREVUE HCG STICK URINE OR SERUM  
K925303 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
PRINCETON BIOMEDITECH ACCUSIGN COC  
K014069 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)  
K014193 Cocaine Metabolites Toxicology / TDM 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK COC  
K014069 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK MET  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET  
K014193 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH ACCUSTIK COC  
K014069 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4  
K014193 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH ACCUSTIK MET  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP COC  
K014069 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)  
K014193 Cocaine Metabolites Toxicology / TDM 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP MET  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
Princeton BioMeditech LifeSign Home Drug Test (MET)  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)  
K014193 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST COCAINE  
K014069 Cocaine Metabolites Toxicology / TDM 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST MARIJUANA  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS COC  
K014069 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)  
K014193 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)  
K014193 Opiates Toxicology / TDM 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS MET  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK COC  
K014069 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK MET  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH STATUS STIK THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET  
K014193 Cocaine Metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Ketone Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Bilirubin Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Blood Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Glucose Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Leukocytes Urinalysis 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Nitrite Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick pH Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Protein Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Urobilinogen Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Specific Gravity Urinalysis 06/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
WAMPOLE PREVUE HCG CASSETTE URINE OR SERUM  
K925125 Urine hCG By Visual Color Comparison Tests Endocrinology 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/COC  
K014067 Cocaine Metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSIGN THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSIGN THC/COC  
K014067 Cocaine Metabolites Toxicology / TDM 06/06/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH ACCUSTIK THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSTIK THC/COC  
K014067 Cocaine Metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSTRIP THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSTRIP THC/COC  
K014067 Cocaine Metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/COC)  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/COC)  
K014067 Cocaine Metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH STATUS DS THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH STATUS DS THC/COC  
K014067 Cocaine Metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH STATUS STIK THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH STATUS STIK THC/COC  
K014067 Cocaine Metabolites Toxicology / TDM 06/06/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM  
K021448 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/06/2002
PRINCETON BIOMEDITECH BIOSIGN HCG SERUM/URINE  
K020439 Urine hCG By Visual Color Comparison Tests Endocrinology 05/23/2002
PRINCETON BIOMEDITECH STATUS HCG SERUM/URINE  
K020439 Urine hCG By Visual Color Comparison Tests Endocrinology 05/23/2002
HYPOGUARD ASSURE BLOOD GLUCOSE SYSTEM  
K980573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/21/2002
Hypoguard Assure II Blood Glucose Monitoring System  
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/21/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Ketone Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Bilirubin Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Leukocytes Urinalysis 05/17/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Nitrite Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick pH Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Protein Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Specific Gravity Urinalysis 05/17/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HYPOGUARD DIASCREEN 1B  
K981555 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 40BL  
K981555 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 40BL  
K981555 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 40BL  
K981555 Urine Qualitative Dipstick Leukocytes Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 40BL  
K981555 Urine Qualitative Dipstick Protein Urinalysis 05/17/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HYPOGUARD DIASCREEN 4NL  
K981555 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4NL  
K981555 Urine Qualitative Dipstick Leukocytes Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4NL  
K981555 Urine Qualitative Dipstick Nitrite Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick Leukocytes Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick Nitrite Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick pH Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick Protein Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick Nitrite Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick pH Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick Protein Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/17/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PSS SELECT REAGENT STRIPS FOR URINALYSIS  
K981555 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 05/17/2002
QUIDEL QUICKVUE ONE-STEP HCG-COMBO  
K020801 Urine hCG By Visual Color Comparison Tests Endocrinology 05/17/2002
QUIDEL QUICKVUE ONE-STEP HCG-URINE  
K020799 Urine hCG By Visual Color Comparison Tests Endocrinology 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Ketone Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Bilirubin Urinalysis 05/17/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Leukocytes Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Nitrite Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick pH Urinalysis 05/17/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Protein Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Specific Gravity Urinalysis 05/17/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS GLUCOSE TEST STRIPS  
K972669 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/10/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS GLUCOSE TEST STRIPS  
K013068 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/10/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS KETONE TEST STRIPS  
K981865 Ketone, Blood General Chemistry 05/10/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS KETONE TEST STRIPS  
K983860 Ketone, Blood General Chemistry 05/10/2002
BAYER DIAGNOSTICS ASCENCIA ELITE BLOOD GLUCOSE METER  
K990649 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/06/2002
BAYER DIAGNOSTICS ASCENCIA ELITE XL BLOOD GLUCOSE METER  
K990649 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/06/2002
BAYER DIAGNOSTICS ASCENSIA ELITE BLOOD GLUCOSE TEST STRIPS  
K991242 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/06/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BAYER DIAGNOSTICS ASCENSIA ELITE DIABETES CARE SYSTEM  
K951537 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/06/2002
BAYER GLUCOMETER DEX 2  
K020210 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
BAYER GLUCOMETER DEX DIABETES CARE SYSTEM  
K020210 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
BAYER GLUCOMETER DEX TEST SENSOR  
K020210 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
BAYER GLUCOMETER ELITE DIABETES CARE SYSTEM  
K020208 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BAYER GLUCOMETER ELITE TEST STRIPS  
K020208 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
BAYER GLUCOMETER ELITE XL DIABETES CARE SYSTEM  
K020208 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS TRIGLYCERIDES TEST STRIPS  (For OTC use)
K000586 Triglyceride General Chemistry 04/30/2002
DE HEALTHCARE PRODUCTS DETECT~OCCULT SLIDE TEST FOR FECAL OCCULT BLOOD  
K902360 Fecal Occult Blood General Chemistry 04/05/2002
HENRY SCHEIN ONE STEP SLIDE TEST FOR FECAL OCCULT BLOOD  
K902360 Fecal Occult Blood General Chemistry 04/05/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
TECO DIAGNOSTICS URINE REAGENT STRIPS (URS-1G)  
K020175 Urine Qualitative Dipstick Glucose Urinalysis 03/21/2002
THERMO BIOSTAR ACCEAVA HCG COMBO URINE/SERUM TEST  
K964155 Urine hCG By Visual Color Comparison Tests Endocrinology 03/21/2002
POLYMEDICA PHARMACEUTICALS, U.S.A. LIBERTY BLOOD GLUCOSE MONITORING SYSTEM  
K014167 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/14/2002
UNIPATH CLEARPLAN EASY OVULATION TEST  
K013874 Ovulation Test (LH) By Visual Color Comparison Endocrinology 03/14/2002
HOME DIAGNOSTICS BROOKS BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS ECKERD BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2002
HOME DIAGNOSTICS KERR DRUG BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2002
HOME DIAGNOSTICS PREFERRED PLUS PHARMACY BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2002
HOME DIAGNOSTICS VALU-RITE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2002
METRIKA A1CNOW FOR PRESCRIPTION HOME USE  
K020234 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 03/08/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Metrika DRX Professional Use Hemoglobin A1c Test  
K020235 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 03/08/2002
SA SCIENTIFIC SAS VALUE HCG  
K020438 Urine hCG By Visual Color Comparison Tests Endocrinology 03/08/2002
GERMAINE LABORATORIES AIMSTEP PREGNANCY  
K013857 Urine hCG By Visual Color Comparison Tests Endocrinology 03/03/2002
ROSS PRODUCTS DIVISION FACT PLUS PRO PREGNANCY TEST  
K921170 Urine hCG By Visual Color Comparison Tests Endocrinology 03/02/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Ketone Urinalysis 02/26/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Bilirubin Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Blood Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Glucose Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Leukocytes Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Nitrite Urinalysis 02/26/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick pH Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Protein Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Creatinine Urinalysis 02/26/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
THERASENSE FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM  
K012014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/25/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
K013778 Cannabinoids (THC) Toxicology / TDM 02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
K013778 Phencyclidine (PCP) Toxicology / TDM 02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
K013778 Cocaine Metabolites Toxicology / TDM 02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
K013778 Methamphetamines Toxicology / TDM 02/21/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
K013778 Morphine Toxicology / TDM 02/21/2002
GDS TECHNOLOGY STAT-SITE M HGB TEST SYSTEM  
K020138 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 02/11/2002
HOME DIAGNOSTICS PRESTIGE IQ BLOOD GLUCOSE SYSTEM {CHAY MEDICAL EXCELSIOR TEST STRIPS} 
K013342 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/07/2002
HOME DIAGNOSTICS PRESTIGE LX BLOOD GLUCOSE SYSTEM {CHAY MEDICAL EXCELSIOR TEST STRIPS} 
K013342 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/07/2002
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM  
K020232 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/07/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
KROGER BLOOD GLUCOSE MONITORING SYSTEM  
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/10/2002
AMERITEK DBEST URINARY TRACT INFECTION TEST KIT  
K990873 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 01/03/2002
CONSUMER CHOICE SYSTEMS URINARY TRACT INFECTION TEST STRIP  
K990873 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 01/03/2002
VICTORCH HCG STRIP  
K013702 Urine hCG By Visual Color Comparison Tests Endocrinology 01/03/2002
VICTORCH HCG TEST CARD  
K013678 Urine hCG By Visual Color Comparison Tests Endocrinology 01/03/2002
Document Test System Name
Analyte		 Analyte Specialty Effective Date
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS PROFESSIONAL AND OTC  
K014099 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/21/2001
ACON STREP A RAPID TEST STRIP  
K010582 Streptococcus, Group A Bacteriology 12/18/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON DS STREP A  
K010582 Streptococcus, Group A Bacteriology 12/18/2001
CAMBRIDGE DIAGNOSTICS INVERNESS MEDICAL EARLY PREGNANCY TEST  
K013907 Urine hCG By Visual Color Comparison Tests Endocrinology 12/18/2001
APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM  
K011233 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS LIFE MEDICAL BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
HOME DIAGNOSTICS LONGS BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
HOME DIAGNOSTICS MEIJER BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
HYPOGUARD ASSURE BLOOD GLUCOSE SYSTEM  
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
Hypoguard Assure II Blood Glucose Monitoring System  
K011233 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LIFESCAN FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM  
K011479 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM  
K011479 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
MEDISENSE SOF-TACT DIABETES MANAGEMENT SYSTEM  
K012975 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9064)  
K013410 Amphetamines Toxicology / TDM 12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9069)  
K013412 Methamphetamines Toxicology / TDM 12/17/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME DRUG TEST (MODEL 9074)  
K013409 Cocaine Metabolites Toxicology / TDM 12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9079)  
K013408 Cannabinoids (THC) Toxicology / TDM 12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9084)  
K013407 Opiates Toxicology / TDM 12/17/2001
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER  
K013068 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
QUIDEL QUICKVUE URINCHEK 10+SG  
K861255 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 12/17/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
QUIDEL QUICKVUE URINCHEK 10+SG  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 12/17/2001
QUIDEL QUICKVUE+ INFECTIOUS MONONUCLEOSIS  (Whole blood)
K902510 Infectious Mononucleosis Antibodies (Mono) General Immunology 12/17/2001
REMEL RIM A.R.C. HCG COMBO PREGNANCY TEST  
K932635 Urine hCG By Visual Color Comparison Tests Endocrinology 12/17/2001
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM  
K012324 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
TCI OVULATION TESTER  
K013323 Fern Test, Saliva Endocrinology 12/05/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
JANT PHARMACAL ACCUSTRIP HCG PREGNANCY TEST  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 12/04/2001
QUIDEL QUICKVUE URINCHEK 2+  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 2+  
K861255 Urine Qualitative Dipstick Protein Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 2+  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick Blood Urinalysis 12/04/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick Leukocytes Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick pH Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick Protein Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 12/04/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Ketone Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Blood Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Nitrite Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick pH Urinalysis 12/04/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Protein Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 12/04/2001
HOME DIAGNOSTICS AMERICAN FARE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
HOME DIAGNOSTICS FAMILY PHARMACY BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS HEALTH CARE AMERICA BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
HOME DIAGNOSTICS HEB INCONTROL BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
HOME DIAGNOSTICS NAVARRO BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
HOME DIAGNOSTICS PATHMARK BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER BEYOND  
K013203 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PROVALIS DIAGNOSTICS GLYCOSAL II HBA1C  
K011933 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/09/2001
BAYER GLUCOMETER DEX 2  
K963500 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/07/2001
BIOCARE CORP. URIMATE REAGENT STRIP FOR URINALYSIS  
K012829 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 11/06/2001
HOME DIAGNOSTICS HOMEBEST BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/06/2001
HOME DIAGNOSTICS LEADER BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/06/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS MEDIC DIRECT BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/06/2001
HOME DIAGNOSTICS PHARMOR BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/06/2001
UNIPATH CLEARBLUE EASY EARLY RESULT PREGNANCY TEST  
K013372 Urine hCG By Visual Color Comparison Tests Endocrinology 11/06/2001
BION DIAGNOSTIC SCIENCES POLY STAT HCG TEST  
K012559 Urine hCG By Visual Color Comparison Tests Endocrinology 10/15/2001
BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST DEVICE  
K013194 hCG, Urine Endocrinology 10/15/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST STRIP  
K013194 hCG, Urine Endocrinology 10/15/2001
FEMTEK PHEM-ALERT  
K012230 Vaginal pH General Chemistry 10/09/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS HEMOCCULT SENSA  
K880499 Fecal Occult Blood General Chemistry 10/05/2001
BERGEN BRUNSWIG TEST FOR FECAL OCCULT BLOOD  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
CIDA COLOCHECK  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
FISHER HEALTHCARE SURE-VUE FECAL OCCULT BLOOD  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
PSS SELECT OCCULT BLOOD TEST  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
STANBIO HEMA-SCREEN  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
STARLINE COLOSCAN  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
HYPOGUARD DIASCREEN REAGENT STRIPS FOR URINALYSIS  
K010973 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 09/21/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BAYER GLUCOMETER DEX TEST SENSOR  
K012205 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/31/2001
HOME DIAGNOSTICS GAMBRO BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/31/2001
HOME DIAGNOSTICS WALGREENS BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/31/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS GASTROCCULT  
K821884 Gastric Occult Blood General Chemistry 08/30/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS GASTROCCULT  
K821884 Gastric pH General Chemistry 08/30/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
MEDICAL INSTRUMENTS PRONTO DRY  
K002451 Helicobacter Pylori Bacteriology 08/30/2001
ACON QUIK-CHECK OVULATION PREDICTOR TEST  
K012252 Ovulation Test (LH) By Visual Color Comparison Endocrinology 08/29/2001
CHEMBIO HCG QUICKSTIX  
K011551 hCG, Urine Endocrinology 08/29/2001
DIAGNOSTIC CHEMICALS IMMUNODIP URINARY ALBUMIN SCREEN  
K994035 Microalbumin General Chemistry 08/29/2001
W.H.P.M. WH ACCU TEST PREGNANCY TEST  
K012284 Urine hCG By Visual Color Comparison Tests Endocrinology 08/29/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
CHEMBIO HCG STAT PAK II  
K011550 Urine hCG By Visual Color Comparison Tests Endocrinology 08/28/2001
HYPOGUARD QUICKTEK BLOOD GLUCOSE METER  
K010039 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/28/2001
ACON QUIK-CHECK HOME PREGNANCY TEST  
K012215 Urine hCG By Visual Color Comparison Tests Endocrinology 08/23/2001
ADVANTAGE DIAGNOSTICS ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST  
K011962 Cannabinoids (THC) Toxicology / TDM 08/23/2001
ADVANTAGE DIAGNOSTICS ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST  
K011962 Cocaine Metabolites Toxicology / TDM 08/23/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ROCHE DIAGNOSTICS ACCU-CHEK INFORM METER OTC  
K012210 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/23/2001
SA SCIENTIFIC SURE-VUE URINE HCG  
K010522 Urine hCG By Visual Color Comparison Tests Endocrinology 08/23/2001
METRIKA A1C NOW  
K000887 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 08/17/2001
EMBRYOTECH LABORATORIES FERTILMARQ HOME DIAGNOSTIC SCREENING TEST FOR MALE INFERTILITY  
K011679 Semen Hematology 08/15/2001
LIFESCAN RUBICON PROTHROMBIN TIME MONITORING SYSTEM  (professional use)
K001699 Prothrombin Time (PT) Hematology 08/06/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LIFESCAN RUBICON PROTHROMBIN TIME MONITORING SYSTEM  (Prescription Home Use)
K001699 Prothrombin Time (PT) Hematology 08/06/2001
BRITE-LIFE BLOOD GLUCOSE SYSTEM IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/03/2001
CVS / PHARMACY BLOOD GLUCOSE SYSTEM IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/03/2001
GOOD NEIGHBOR PHARMACY BLOOD GLUCOSE SYSTEM IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/03/2001
SAV-ON OSCO BY ALBERTSON'S BLOOD GLUCOSE SYSTEM IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/03/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
OSTEX INTERNATIONAL OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE  
K011052 COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX) Endocrinology 07/30/2001
KDK CORPORATION LACTATE PRO SYSTEM  (For OTC use)
K980908 Lactic Acid (Lactate) General Chemistry 07/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9078T)  
K010654 Cannabinoids (THC) Toxicology / TDM 07/27/2001
SA SCIENTIFIC SURE VUE SERUM/URINE HCG  
K010593 Urine hCG By Visual Color Comparison Tests Endocrinology 07/27/2001
QUIDEL QUICKVUE DIPSTICK STREP A  (DIRECT THROAT SWAB)
K011097 Streptococcus, Group A Bacteriology 07/26/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ITC PROTIME MICROCOAGULATION SYSTEM  (Prescription Home Use)
K010599 Prothrombin Time (PT) Hematology 07/23/2001
ITC PROTIME MICROCOAGULATION SYSTEM  (professional use)
K010599 Prothrombin Time (PT) Hematology 07/23/2001
CHEMBIO SURE CHECK OVULATION PREDICTOR  
K010244 Luteinizing Hormone (LH) Endocrinology 07/20/2001
HOME DIAGNOSTICS MEDICINE SHOPPE BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/20/2001
IVERNESS MEDICAL TECHNOLOGY INDUO BLOOD GLUCOSE METER  
K011616 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/20/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME DRUG TEST (MODEL 9068T)  
K010653 Methamphetamines Toxicology / TDM 07/20/2001
ABB0TT SIGNIFY H. PYLORI WHOLE BLOOD  
K990892 Helicobacter Pylori Antibodies General Immunology 07/17/2001
ICON DS STREP A  
K010582 Streptococcus, Group A Bacteriology 07/17/2001
FOREFRONT DIAGNOSTICS DRUGFREE@HOME THC/COC TEST KIT  
K002253 Cannabinoids (THC) Toxicology / TDM 07/10/2001
FOREFRONT DIAGNOSTICS DRUGFREE@HOME THC/COC TEST KIT  
K002253 Cocaine Metabolites Toxicology / TDM 07/10/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
ADVANTAGE DIAGNOSTICS ADVANTAGE THC (MARIJUANA) HOME DRUG TEST  
K010921 Cannabinoids (THC) Toxicology / TDM 07/03/2001
HOME DIAGNOSTICS APICAL BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
HOME DIAGNOSTICS BROOKS PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
HOME DIAGNOSTICS DIABETIC.COM BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
HOME DIAGNOSTICS EPIC PHARMACIES BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS FARMACIAS EL AMAL BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
HOME DIAGNOSTICS MEDPLUS PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
SA SCIENTIFIC SURE-VUE SERUM/URINE HCG-STAT  
K990684 hCG, Urine Endocrinology 07/03/2001
SA SCIENTIFIC HEB ONE-STEP PREGNANCY TEST  
K991193 hCG, Urine Endocrinology 07/02/2001
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MONITORING SYSTEM  
K010553 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/22/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
THERASENSE FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM  
K992684 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/22/2001
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM  
K011738 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/20/2001
WAMPOLE PREVUE B. BURGDORFERI  
K981913 Lyme Disease Antibodies (Borrelia Burgdorferi Abs) General Immunology 06/19/2001
BIOMEDICAL PRODUCTS DOUBLE-CHEK STRIP URINALYSIS  
K993850 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 06/12/2001
SA SCIENTIFIC SAS ULTRA HCG SERUM/URINE  
K990684 Urine hCG By Visual Color Comparison Tests Endocrinology 06/04/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
GENZYME SIGNIFY HCG URINE/SERUM TEST  
K964155 Urine hCG By Visual Color Comparison Tests Endocrinology 05/02/2001
BAYER MULTISTIX PRO 10LS REAGENT STRIPS  
K992257 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 05/01/2001
BAYER MULTISTIX PRO 10LS REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Creatinine Urinalysis 05/01/2001
BAYER MULTISTIX PRO 11 REAGENT STRIPS  
K992257 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 05/01/2001
BAYER MULTISTIX PRO 11 REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Creatinine Urinalysis 05/01/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BAYER MULTISTIX PRO 7G REAGENT STRIPS  
K992257 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 05/01/2001
BAYER MULTISTIX PRO 7G REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Creatinine Urinalysis 05/01/2001
TECO DIAGNOSTICS URS-1K URINE REAGENT STRIPS  (Over-The-Counter)
K003987 Ketone, Urine General Chemistry 04/30/2001
BECKMAN COULTER ICON DS HCG TEST STRIP  (urine)
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9063 T)  
K010645 Amphetamines Toxicology / TDM 04/23/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME DRUG TEST (MODEL 9073 T)  
K010650 Cocaine Metabolites Toxicology / TDM 04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9083 T)  
K010646 Opiates Toxicology / TDM 04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9133 T)  
K010651 Phencyclidine (PCP) Toxicology / TDM 04/23/2001
CHOLESTECH L.D.X. {Whole blood} 
K991834 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 04/13/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 Amphetamines Toxicology / TDM 04/04/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 Cannabinoids (THC) Toxicology / TDM 04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 Cocaine Metabolites Toxicology / TDM 04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 Opiates Toxicology / TDM 04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 Methamphetamine/Amphetamine Toxicology / TDM 04/04/2001
CYGNUS, INC. GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER  
P990026 Glucose, Fluid (Approved By Fda For Prescription Home Use) General Chemistry 03/28/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS PRESTIGE IQ BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/27/2001
ROCHE DIAGNOSTICS ACCU-CHEK ADVANTAGE {ROCHE DIAGNOSTICS ACCU-CHEK COMFORT CURVE TEST STRIP} 
K010362 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/27/2001
ROCHE DIAGNOSTICS ACCU-CHEK COMPLETE SYSTEM {ROCHE DIAGNOSTICS ACCU-CHEK COMFORT CURVE TEST STRIP} 
K010362 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/27/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON FX STREP A IMMUNOCHEMICAL STREP A ANTIGEN TEST  
K960712 Streptococcus, Group A Bacteriology 03/16/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9068)  
K003858 Methamphetamines Toxicology / TDM 02/27/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 Amphetamines Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 Cannabinoids (THC) Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 Cocaine Metabolites Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 Opiates Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 Methamphetamines Toxicology / TDM 02/27/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K003858 Cannabinoids (THC) Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K003858 Opiates Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K003858 Methamphetamines Toxicology / TDM 02/27/2001
BIOMERICA EZ-HCG URINE (PREGNANCY TEST)  
K003856 Urine hCG By Visual Color Comparison Tests Endocrinology 02/26/2001
HOME DIAGNOSTICS GENICARE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
HOME DIAGNOSTICS MEDHOME DIRECT BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2001
HOME DIAGNOSTICS PHARMOR BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2001
HOME DIAGNOSTICS VITALCARE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2001
LIFESCAN SURESTEP PRO  
K970556 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/25/2001
DIAGNOSTICA, INC. EASE-A-CULT SENSITIVE  
K002756 Fecal Occult Blood General Chemistry 02/21/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BAYER MICROALBUSTIX REAGENT STRIPS (OTC)  
K991315 Microalbumin General Chemistry 02/14/2001
BAYER MICROALBUSTIX REAGENT STRIPS (OTC)  
K991315 Creatinine General Chemistry 02/14/2001
INTERNATIONAL NEWTECH DEVELOP. URINALYSIS REAGENT STRIP (10 PARAMETERS)  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/05/2001
ENTERIX !NSURE FECAL OCCULT BLOOD TEST  
K002457 Fecal Occult Blood General Chemistry 01/31/2001
MEDTEK DIAGNOSTICS INSTACCULT  
K002930 Fecal Occult Blood General Chemistry 01/30/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM  
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM  
K002624 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
HEALTH CARE AMERICA BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
HUMANA BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
STC TECHNOLOGIES ORASURE Q.E.D. A-150 SALIVA ALCOHOL TEST  
K894001 Alcohol, Saliva Toxicology / TDM 01/22/2001
Document Test System Name
Analyte		 Analyte Specialty Effective Date
VALU-RITE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
WEIS PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
GENUA MENOPAUSE MONITOR TEST  (qualitative)
K002450 Follicle Stimulating Hormone (FSH) Endocrinology 01/12/2001
ACON ONE STEP PREGNANCY TEST STRIP (URINE)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 12/19/2000
KINRAY PREFERRED PLUS BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/19/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LIFESCAN SATURN BLOOD GLUCOSE MONITORING TEST STRIP  
K001441 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/19/2000
STC TECHNOLOGIES ORASURE Q.E.D. A-350 SALIVA ALCOHOL TEST  
K903235 Alcohol, Saliva Toxicology / TDM 12/19/2000
THERASENSE FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM  
K000582 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/19/2000
ACCUNATE-CHOICE  
K992397 Urine hCG By Visual Color Comparison Tests Endocrinology 12/13/2000
DISCOUNT DRUG MART FOOD FAIR BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
DRUG EMPORIUM BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
DUANE READE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
EXPRESS MED BLOOD GLYCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
FACT PLUS PRO PREGNANCY TEST  
K990576 Urine hCG By Visual Color Comparison Tests Endocrinology 12/13/2000
FACT PLUS SELECT PREGNANCY TEST  
K965184 Urine hCG By Visual Color Comparison Tests Endocrinology 12/13/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
GIANT EAGLE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
GOOD NEIGHBOR PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
HELENA LABORATORIES COLOSCREEN-ES  
K003359 Fecal Occult Blood General Chemistry 12/13/2000
KERR BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
MEDIC BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
SENTRY BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
SHOP RITE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
BECKMAN COULTER INC'S ICON 25 HCG  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 12/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 Cannabinoids (THC) Toxicology / TDM 12/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 Cocaine Metabolites Toxicology / TDM 12/06/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 Opiates Toxicology / TDM 12/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 Methamphetamines Toxicology / TDM 12/06/2000
BECKMAN COULTER INC'S ICON 25 HCG  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 12/04/2000
ZYMETX ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES  
K982429 Influenza A/B Virology 12/04/2000
AMERITEK DBEST HCG 2 IU/ML TEST KIT  
K001215 Urine hCG By Visual Color Comparison Tests Endocrinology 11/30/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
METRIKA DRX HBA1C PRESCRIPTION HOME USE  
K000885 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/30/2000
BRITE-LIFE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2000
LIFE MEDICAL BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2000
MEIJER BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2000
SAV-ON OSCO BY ALBERTSON'S BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
TRUE CARE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2000
Metrika DRX Professional Use Hemoglobin A1c Test  
K000887 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/27/2000
MEDISENSE SOF-TACT DIABETES MANAGEMENT SYSTEM  
K001993 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/20/2000
INVERNESS MEDICAL EARLY OVULATION PREDICTOR  (stick)
K002867 Luteinizing Hormone (LH) Endocrinology 10/23/2000
Quidel Quickvue Influenza A/B  
K991633 Influenza A/B Virology 10/04/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LIFESCAN SURESTEP FLEXX BLOOD GLUCOSE MONITORING SYSTEM  
K970556 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2000
ACON HCG URINE/SERUM ONE STEP PREGNANCY TEST DEVICE  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 09/15/2000
ABBOTT MEDISENSE RELION BLOOD GLUCOSE TEST SYSTEM  
K944195 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/14/2000
WYNTEK DIAGNOSTICS SIGNIFY MONO TEST  (For whole blood)
K972231 Infectious Mononucleosis Antibodies (Mono) General Immunology 09/07/2000
Roche Diagnostics CoaguChek S System  
K994349 Prothrombin Time (PT) Hematology 09/06/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM  
K002134 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2000
LIFESCAN ONE TOUCH IIB BLOOD GLUCOSE METER {INBIOS INTERNATIONAL, INC. GENERIC BLOOD GLUCOSE TEST STRIP} 
K001092 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/01/2000
LIFESCAN ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM {INBIOS INTERNATIONAL, INC. GENERIC BLOOD GLUCOSE TEST STRIP} 
K001092 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/01/2000
SELFCARE, INC., FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM  
K001427 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2000
LIFESTREAM TECHNOLOGIES PERSONAL CHOLESTEROL MONITOR  (For OTC use)
K000610 Cholesterol General Chemistry 07/19/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
UNIPATH CLEARPLAN EASY FERTILITY MONITOR  
K981207 Ovulation Test (LH) By Visual Color Comparison Endocrinology 07/17/2000
UNIPATH CLEARPLAN EASY FERTILITY MONITOR  
K981207 Estrone-3 Glucuronide Endocrinology 07/17/2000
TRINITY BIOTECH UNI-GOLD H. PYLORI  
K991697 Helicobacter Pylori Antibodies General Immunology 07/11/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC)  
K993663 Cannabinoids (THC) Toxicology / TDM 07/11/2000
WYNTEK DIAGNOSTICS OSOM ULTRA STREP A  
K992658 Streptococcus, Group A Bacteriology 07/06/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
POLYMER TECHNOLOGY SYSTEMS, BIOSCANNER  (For OTC use)
K000586 Triglyceride General Chemistry 06/29/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)  
K994138 Cannabinoids (THC) Toxicology / TDM 06/29/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)  
K994138 Cocaine Metabolites Toxicology / TDM 06/29/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)  
K994138 Methamphetamines Toxicology / TDM 06/29/2000
WORLDWIDE MEDICAL FIRST CHECK PANEL 2 (THC/COC)  
K994139 Cannabinoids (THC) Toxicology / TDM 06/29/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
WORLDWIDE MEDICAL FIRST CHECK PANEL 2 (THC/COC)  
K994139 Cocaine Metabolites Toxicology / TDM 06/29/2000
MIZUHO USA ABSOLUTE HCG PREGNANCY TEST  
K000844 Urine hCG By Visual Color Comparison Tests Endocrinology 06/15/2000
HOME DIAGNOSTICS NAVARRO BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/09/2000
QUIDEL QUICKVUE URINE CHECK  
K861255 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 05/23/2000
LIFESIGN LLC STATUS STREP A  
K983386 Streptococcus, Group A Bacteriology 05/17/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PRINCETON BIOMEDITECH BIOSTREP A  
K983386 Streptococcus, Group A Bacteriology 05/17/2000
WYNTEK DIAGNOSTICS SIGNIFY HCG URINE TEST  
K974159 Urine hCG By Visual Color Comparison Tests Endocrinology 05/02/2000
SA SCIENTIFIC SAS SERUM/URINE HCG  
K990684 Urine hCG By Visual Color Comparison Tests Endocrinology 04/26/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9063)  
K994237 Amphetamines Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9068)  
K994233 Methamphetamines Toxicology / TDM 04/19/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME DRUG TEST (MODEL 9073)  
K994219 Cocaine Metabolites Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9078)  
K994220 Cannabinoids (THC) Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9083)  
K994234 Opiates Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9133)  
K994236 Phencyclidine (PCP) Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9170)  
K991641 Cannabinoids (THC) Toxicology / TDM 04/19/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME DRUG TEST (MODEL 9170)  
K991641 Cocaine Metabolites Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9171)  
K991824 Opiates Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9171)  
K991824 Methamphetamines Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K992217 Cannabinoids (THC) Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K992217 Opiates Toxicology / TDM 04/19/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K992217 Methamphetamines Toxicology / TDM 04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 Amphetamines Toxicology / TDM 04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 Phencyclidine (PCP) Toxicology / TDM 04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 Cocaine Metabolites Toxicology / TDM 04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 Opiates Toxicology / TDM 04/19/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 Methamphetamines Toxicology / TDM 04/19/2000
POLYMEDCO POLY STAT A (II)  
K973111 Streptococcus, Group A Bacteriology 04/13/2000
JANT PHARMACAL H. PYLORI  
K990892 Helicobacter Pylori Antibodies General Immunology 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 04/03/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Blood Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 04/03/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick pH Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Protein Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 04/03/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
POLYMER TECHNOLOGY SYSTEMS, BIOSCANNER TEST STRIPS CHOLESTEROL  (For professional use)
K990247 Cholesterol General Chemistry 04/03/2000
ROCHE DIAGNOSTICS CORP. ACCU-CHEK ADVANTAGE METER  
K000365 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/01/2000
ROCHE DIAGNOSTICS CORP. ACCU-CHEK COMPLETE SYSTEM  
K000364 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/01/2000
SELFCARE, INC., FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM  
K000583 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/15/2000
TECO DIAGNOSTICS URITEK TC-101 URINE STRIP READER  
X000001 Urine Qualitative Dipstick Chemistries Urinalysis 03/10/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
TECO DIAGNOSTICS URS-1K URINE REAGENT STRIPS  
X000002 Urine Qualitative Dipstick Ketone Urinalysis 03/10/2000
ABBOTT LABORATORIES, MEDISENSE OPTIUM ADVANCED DIABETES MANAGEMENT SYSTEM  
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/25/2000
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM  
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/25/2000
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM  
K983504 Ketone, Blood General Chemistry 02/25/2000
POLYMEDCO POLY STAT HCG  
K932635 Urine hCG By Visual Color Comparison Tests Endocrinology 02/25/2000
Document Test System Name
Analyte		 Analyte Specialty Effective Date
AVOCET ACUSURE SYSTEM  (Prescription Home Use)
K994006 Prothrombin Time (PT) Hematology 02/16/2000
AVOCET AVOSURE PT SYSTEM  (Prescription Home Use)
K991286 Prothrombin Time (PT) Hematology 02/16/2000
POLYMEDCO POLYSTAT MONO  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/14/2000

Database Updated 02/06/2009

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