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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-jcv antibody detection assay
De Novo Number DEN120008
510(K) Number K112394
Device Name STRATIFY JCV(TM) ANTIBODY
Requester
focus diagnostics, inc.
11331 valley view st.
cypress,  CA  90630
Contact tara viviani
Regulation Number866.3336
Classification Product Code
OYP  
Date Received01/06/2012
Decision Date 01/20/2012
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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