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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
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