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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
510(k) Number K083615
Device Name EUROIMMUN ANTI BP 180-4X 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 Number866.5660
Classification Product Code
OEG  
Date Received12/08/2008
Decision Date 03/16/2009
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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