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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
Device Name VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
Original Applicant
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
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 (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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