FDA 510(k) Application Details - K162395

Device Classification Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites   More FDA Info for this Device
510(K) Number	K162395
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant	MP BIOMEDICALS, LLC 1429 ROLLINS ROAD BURLINGAME, CA 94010 US Other 510(k) Applications for this Company
Contact	STAR HAN Other 510(k) Applications for this Contact
Regulation Number	862.3250   More FDA Info for this Regulation Number
Classification Product Code	DIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2016
Decision Date	06/02/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review