FDA 510(k) Application Details - K013778

Device Classification Name	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter   More FDA Info for this Device
510(K) Number	K013778
Device Name	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Applicant	ADVANTAGE DIAGNOSTICS CORP. 1201 DOUGLAS AVE. REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	JANIS FREESTONE 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	11/13/2001
Decision Date	02/07/2002
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