FDA 510(k) Application Details - K153596

Device Classification Name	More FDA Info for this Device
510(K) Number	K153596
Device Name	ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
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	POX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2015
Decision Date	08/09/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review