FDA 510(k) Application Details - K040327

Device Classification Name	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter   More FDA Info for this Device
510(K) Number	K040327
Device Name	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Applicant	ACCU-STAT DIAGNOSTICS, INC. 11 ORCHARD RD., SUITE 108 LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	JAMES G BARRONS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MVO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2004
Decision Date	04/19/2004
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