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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 voriconazole test system
De Novo Number DEN160033
Device Name ARK Voriconazole II Assay Test System
Requester
ARK DIAGNOSTICS, INC
48089 fremont blvd.
fremont,  CA  94538
Contact kenneth c. kasper
Regulation Number862.3970
Classification Product Code
PUJ  
Date Received07/15/2016
Decision Date 05/05/2017
Decision granted (DENG)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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