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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 K041444
Device Name BIO-RAD D-10 DUAL PROGRAM
Applicant
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact JACKIE BUCKLEY
Correspondent
California Department of Health Services
1500 Capitol Ave.
Mailstop 7602
Sacramento,  CA  95814
Correspondent Contact ALFREDO J QUATTRONE
Regulation Number864.7470
Classification Product Code
LCP  
Date Received06/01/2004
Decision Date 06/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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