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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 K092353
Device Name MONOLISA ANTI-HAV IGM EIA
Applicant
Bio-Rad Laboratories, Inc.
6565 185th Ave., NE
Redmond,  WA  98052
Applicant Contact LINDA STASWICK
Correspondent
Bio-Rad Laboratories, Inc.
6565 185th Ave., NE
Redmond,  WA  98052
Correspondent Contact LINDA STASWICK
Regulation Number866.3310
Classification Product Code
LOL  
Subsequent Product Code
JJE  
Date Received08/04/2009
Decision Date 10/29/2009
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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