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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 K090699
Device Name VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
Applicant
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact JACKIE H BUCKLEY
Correspondent
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact JACKIE H BUCKLEY
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/17/2009
Decision Date 07/27/2009
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 No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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