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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 K130860
Device Name VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
Applicant
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
4000 ALFRED NOBEL DRIVE
HERCULES,  CA  94547
Applicant Contact EBONY MCKINNIES
Correspondent
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
4000 ALFRED NOBEL DRIVE
HERCULES,  CA  94547
Correspondent Contact EBONY MCKINNIES
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JPD  
Date Received03/28/2013
Decision Date 04/25/2013
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
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