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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay Gentamicin
510(k) Number K972609
Device Name VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact JOHN W NELSON
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact JOHN W NELSON
Regulation Number862.3450
Classification Product Code
LCQ  
Date Received07/11/1997
Decision Date 08/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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