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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name anti-phospholipase a2 receptor
De Novo Number DEN140002
510(K) Number K132379
Device Name EUROIMMUN ANTI-PLA2R IFA
Requester
euroimmun us
1100 the american rd.
morris plains,  NJ  07950
Contact michael locke
Regulation Number866.5780
Classification Product Code
PGV  
Date Received03/28/2014
Decision Date 05/29/2014
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Immunology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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