FDA 510(k) Application Details - K132812

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K132812
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	UCP BIOSCIENCES, INC. 1445 KOLL CIRCLE, STE. 111 SAN JOSE, CA 95112 US Other 510(k) Applications for this Company
Contact	NANCY CHEN 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	09/09/2013
Decision Date	03/06/2014
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