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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 K140225
Device Name ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
Applicant
Phadia US, Inc.
Munzinger Strasse 7
Freiburg Im Breisgau,  DE 79111
Applicant Contact MARTIN MANN
Correspondent
Phadia US, Inc.
Munzinger Strasse 7
Freiburg Im Breisgau,  DE 79111
Correspondent Contact MARTIN MANN
Regulation Number866.5660
Classification Product Code
MOB  
Subsequent Product Codes
JJY   MVJ  
Date Received01/29/2014
Decision Date 10/27/2014
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
Recalls CDRH Recalls
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