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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 antibodies, saccharomyces cerevisiae (s.cerevisiae)
De Novo Number DEN000007
510(K) Number K000732
Device Name QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
Requester
inova diagnostics, inc.
10180 scripps ranch blvd.
san diego,  CA  92131
Contact brys c myers
Regulation Number866.5785
Classification Product Code
NBT  
Date Received07/18/2000
Decision Date 08/16/2000
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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