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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 K142448
Device Name VARIANT II TURBO HbA1c Kit - 2.0
Applicant
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact Jackie Buckley
Correspondent
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact Jackie Buckley
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
JKA  
Date Received09/02/2014
Decision Date 03/24/2015
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
Predetermined Change
Control Plan Authorized		 No
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