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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 K082050
Device Name LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Applicant Contact CAROL A DEPOUW
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Correspondent Contact CAROL A DEPOUW
Regulation Number866.3310
Classification Product Code
LOL  
Date Received07/18/2008
Decision Date 11/03/2008
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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