FDA 510(k) Application Details - K963233

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K963233
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	EDITEK, INC. 1238 ANTHONY RD. BURLINGTON, NC 27215 US Other 510(k) Applications for this Company
Contact	CAROLE GOLDEN 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	08/19/1996
Decision Date	10/31/1996
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