FDA 510(k) Application Details - K080381

Device Classification Name	Gas Chromatography, Methamphetamine   More FDA Info for this Device
510(K) Number	K080381
Device Name	Gas Chromatography, Methamphetamine
Applicant	QUEST DIAGNOSTICS, INC. 10101 RENNER BLVD. LENEXA, KS 66219-9752 US Other 510(k) Applications for this Company
Contact	LIUMING YU Other 510(k) Applications for this Contact
Regulation Number	862.3610   More FDA Info for this Regulation Number
Classification Product Code	LAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2008
Decision Date	06/25/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review