FDA 510(k) Application Details - K991465

Device Classification Name	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter   More FDA Info for this Device
510(K) Number	K991465
Device Name	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Applicant	TEXAS IMMUNOLOGY, INC. 12524 FM 3226 TYLER, TX 75707 US Other 510(k) Applications for this Company
Contact	CHARLES W GILL 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	04/27/1999
Decision Date	12/10/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review