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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 K090699
Device Name VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
Applicant
BIO-RAD LABORATORIES, INC.
4000 ALFRED NOBEL DR
HERCULES,  CA  94547
Applicant Contact JACKIE H BUCKLEY
Correspondent
BIO-RAD LABORATORIES, INC.
4000 ALFRED NOBEL DR
HERCULES,  CA  94547
Correspondent Contact JACKIE H BUCKLEY
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/17/2009
Decision Date 07/27/2009
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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