FDA 510(k) Application Details - K042725

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K042725
Device Name	Enzyme Immunoassay, Opiates
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	862.3650   More FDA Info for this Regulation Number
Classification Product Code	DJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2004
Decision Date	07/06/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review