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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K172582
Device Name EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern
Applicant
Euroimmun Us, Inc.
1 Bloomfield Ave.
Mountain Lakes,  NJ  07046
Applicant Contact Michael A. Locke
Correspondent
Euroimmun Us, Inc.
1 Bloomfield Ave.
Mountain Lakes,  NJ  07046
Correspondent Contact Michael A. Locke
Regulation Number866.5660
Classification Product Code
MOB  
Subsequent Product Codes
MVJ   PIV  
Date Received08/28/2017
Decision Date 05/24/2018
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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