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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 K063643
Device Name MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
Applicant
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547
Applicant Contact JACKIE BUCKLEY
Correspondent
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547
Correspondent Contact JACKIE BUCKLEY
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JPD  
Date Received12/07/2006
Decision Date 12/27/2006
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
Recalls CDRH Recalls
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