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CLIA record K052719 and corresponding 510(K) Premarket Notification information
Test System Name | Bayer Clinitek 50 Urine Chemistry Analyzer {Jant Pharmacal Accutest URS-10 Urine Reagent Strips} |
Document Number |
K052719 |
Analyte Name | Urine Qualitative Dipstick Bilirubin |
Analyte Specialty | Urinalysis |
Complexity | MODERATE |
Effective Date | 09/18/2008 |
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510(k) Premarket Notification Database
Device Classification Name |
blood, occult, colorimetric, in urine
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510(k) Number | K052719 |
Device Name | URITEST 10 URINALYSIS REAGENT STRIPS |
Applicant |
ARJ MEDICAL, INC.
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209 state street |
oldsmar,
FL
34677 |
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Contact | aaron behar |
Regulation Number | 864.6550 |
Classification Product Code |
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Subsequent Product Codes |
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Date Received | 09/29/2005 |
Decision Date | 12/05/2006 |
Decision |
substantially equivalent - CLIA submission (CS) |
Classification Advisory Committee |
Hematology
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Review Advisory Committee |
Clinical Chemistry
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Statement/Summary/Purged Status |
Summary only
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summary |
summary
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FDA Review |
Decision Summary
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Type |
Traditional
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Reviewed by Third Party |
No
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Expedited Review |
No
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