FDA 510(k) Application Details - K201089

Device Classification Name	Immunoassay, Anti-Seizure Drug   More FDA Info for this Device
510(K) Number	K201089
Device Name	Immunoassay, Anti-Seizure Drug
Applicant	ARK Diagnostics, Inc. 48089 Fremont Boulevard Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Thomas Houts Other 510(k) Applications for this Contact
Regulation Number	862.3350   More FDA Info for this Regulation Number
Classification Product Code	NWM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2020
Decision Date	08/05/2021
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