FDA 510(k) Application Details - K182779

Device Classification Name	Enzyme Immunoassay, Methadone   More FDA Info for this Device
510(K) Number	K182779
Device Name	Enzyme Immunoassay, Methadone
Applicant	ARK Diagnostics, Inc. 48089 Fremont Boulevard Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Cherry Mun Other 510(k) Applications for this Contact
Regulation Number	862.3620   More FDA Info for this Regulation Number
Classification Product Code	DJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2018
Decision Date	11/21/2018
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