FDA 510(k) Application Details - K982621

Device Classification Name	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter   More FDA Info for this Device
510(K) Number	K982621
Device Name	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Applicant	PHAMATECH 9265 ACTIVITY RD., #112-113 SAN DIEGO, CA 92126 US Other 510(k) Applications for this Company
Contact	CARL A MONGIOVI 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	07/28/1998
Decision Date	10/16/1998
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