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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hepatitis A Test (Antibody And Igm Antibody)
510(k) Number K063318
Device Name MONOLISA ANTI-HAV EIA
Applicant
Bio-Rad Laboratories
3 Bd Raymond Poincare
Marnes-La-Coquette
Hauts-De-Seine,  FR 92430
Applicant Contact MANUELA KAUL
Correspondent
Bio-Rad Laboratories
3 Bd Raymond Poincare
Marnes-La-Coquette
Hauts-De-Seine,  FR 92430
Correspondent Contact MANUELA KAUL
Regulation Number866.3310
Classification Product Code
LOL  
Date Received11/02/2006
Decision Date 05/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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