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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
510(k) Number K083381
Device Name EUROIMMUN ANTI-DSDNA-NCX 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 Number866.5100
Classification Product Code
LRM  
Date Received11/14/2008
Decision Date 04/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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