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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hemoglobin a1c test system
510(k) Number K142595
Device Name VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
Applicant
ORTHO CLINICAL DIAGNOSTICS
100 INDIGO CREEK DRIVE
ROCHESTER,  NY  14626
Applicant Contact Bradley P Boyer
Correspondent
ORTHO CLINICAL DIAGNOSTICS
100 INDIGO CREEK DRIVE
ROCHESTER,  NY  14626
Correspondent Contact Bradley P Boyer
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Codes
JIT   JJY  
Date Received09/15/2014
Decision Date 06/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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