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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 sirolimus test system
De Novo Number DEN040008
510(K) Number K034069
Device Name CEDIA SIROLIMUS ASSAY
Requester
microgenics corp.
46360 fremont blvd.
fremont,  CA  94538
Contact david casal
Regulation Number862.3840
Classification Product Code
NRP  
Date Received06/17/2004
Decision Date 07/28/2004
Decision granted (DENG)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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