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CLIA record K052719 and corresponding
510(K) Premarket Notification information

Test System NameBayer Clinitek 50 Urine Chemistry Analyzer  {Jant Pharmacal Accutest URS-10 Urine Reagent Strips} 
Document Number K052719
Analyte NameUrine Qualitative Dipstick Bilirubin
Analyte SpecialtyUrinalysis
ComplexityMODERATE
Effective Date09/18/2008

510(k) Premarket Notification Database

Device Classification Name blood, occult, colorimetric, in urine
510(k) NumberK052719
Device NameURITEST 10 URINALYSIS REAGENT STRIPS
Applicant
ARJ MEDICAL, INC.
209 state street
oldsmar,  FL  34677
Contactaaron behar
Regulation Number864.6550
Classification Product Code
JIO
Subsequent Product Codes
CDM CEN JIL JIN JIR
JJB JMT LJX
Date Received09/29/2005
Decision Date 12/05/2006
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Clinical Chemistry
Statement/Summary/Purged Status Summary only
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 02/06/2009

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