FDA 510(k) Application Details - K042726

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K042726
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	QUEST DIAGNOSTICS, INC. 4230 BURNHAM AVE. LAS VEGAS, NV 89119-5410 US Other 510(k) Applications for this Company
Contact	JAMES A BOURLAND 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	10/01/2004
Decision Date	07/28/2005
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