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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 K063400
Device Name VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
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 Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
LDM  
Date Received11/09/2006
Decision Date 12/01/2006
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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