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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 K031043
Device Name D-10 HEMOGLOBIN A1C
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  
Date Received04/01/2003
Decision Date 08/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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