FDA 510(k) Application Details - K974582

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K974582
Device Name	Enzyme Immunoassay, Phencyclidine
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	862.3100   More FDA Info for this Regulation Number
Classification Product Code	LCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/1997
Decision Date	02/04/1998
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