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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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