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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 K140801
Device Name VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
Applicant
BIO-RAD LABORATORIES, INC.
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547
Applicant Contact EBONY MCKINNIES
Correspondent
BIO-RAD LABORATORIES, INC.
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547
Correspondent Contact EBONY MCKINNIES
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/31/2014
Decision Date 06/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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