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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 K151321
FOIA Releasable 510(k) K151321
Device Name D-100 HbA1c, D-100 HbA1c Calibrator Pack
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 Codes
JIT   LCP  
Date Received05/18/2015
Decision Date 12/09/2015
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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