FDA 510(k) Application Details - K152590

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K152590
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	CORETESTS, INC 6190 YARROW DRIVE CARLSBAD, CA 92011 US Other 510(k) Applications for this Company
Contact	ERIC SUN Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	DKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2015
Decision Date	04/15/2016
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