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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 K173792
Device Name EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
Applicant
Phadia AB
Rapsgatan 7P
Uppsala,  SE SE 754 50
Applicant Contact Carina Magnusson
Correspondent
Phadia US Inc.
4169 Commercial Avenue
Portage,  MI  49002
Correspondent Contact Martin Robert Mann
Regulation Number866.5660
Classification Product Code
MOB  
Subsequent Product Code
MVJ  
Date Received12/14/2017
Decision Date 03/13/2018
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
Recalls CDRH Recalls
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