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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K092736
Device Name EUROIMMUN ANTI-M2-3E ELISA (IGG)
Applicant
Euroimmun Us, Inc.
95 Washington St.
Morristown,  NJ  07960
Applicant Contact KATHRYN KOHL
Correspondent
Euroimmun Us, Inc.
95 Washington St.
Morristown,  NJ  07960
Correspondent Contact KATHRYN KOHL
Regulation Number866.5090
Classification Product Code
DBM  
Date Received09/04/2009
Decision Date 09/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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