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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name anti-phospholipase a2 receptor
510(k) Number K132195
Device Name EUROIMMUN ANTI-PLA2R ELISA (IGG)
Applicant
EUROIMMUN US INC
1100 THE AMERICAN ROAD
MORRIS PLAINS,  NJ  07950
Applicant Contact MICHAEL LOCKE
Correspondent
EUROIMMUN US INC
1100 THE AMERICAN ROAD
MORRIS PLAINS,  NJ  07950
Correspondent Contact MICHAEL LOCKE
Regulation Number866.5780
Classification Product Code
PGV  
Date Received07/15/2013
Decision Date 06/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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