FDA 510(k) Application Details - K964355

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K964355
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 BRANCHBURG, NJ 08876-3771 US Other 510(k) Applications for this Company
Contact	ALEX WESOLOWSKI 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	11/01/1996
Decision Date	12/13/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review