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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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