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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 K984268
Device Name VARIANT II HEMOGLOBIN A1C PROGRAM
Applicant
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547 -1803
Applicant Contact JULIET CARRARA
Correspondent
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547 -1803
Correspondent Contact JULIET CARRARA
Regulation Number864.7470
Classification Product Code
LCP  
Date Received11/30/1998
Decision Date 12/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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