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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K122472
Models 270-2455, 270-2600 & 270-2601
Device Name VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
Original Applicant
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVISION
4000 alfred nobel drive
hercules,  CA  94547
Original Contact jackie buckley
Regulation Number864.7470
Classification Product Code
LCP  
Date Received08/14/2012
Decision Date 10/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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