FDA 510(k) Application Details - K973122

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K973122
Device Name	Enzyme Immunoassay, Cannabinoids
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	862.3870   More FDA Info for this Regulation Number
Classification Product Code	LDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/1997
Decision Date	09/25/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review