FDA 510(k) Application Details - DEN160033

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160033
Device Name	ARK Voriconazole II Assay Test System
Applicant	ARK DIAGNOSTICS, INC 48089 FREMONT BLVD. FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	Kenneth C. Kasper Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2016
Decision Date	05/05/2017
Decision	DENG -
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review