FDA 510(k) Application Details - K122703

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K122703
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	BIOPHOR DIAGNOSTICS, INC. 1201 DOUGLAS AVE REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	Nathaniel G Butlin Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	LCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2012
Decision Date	04/25/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review