FDA 510(k) Application Details - K013407

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K013407
Device Name	Enzyme Immunoassay, Opiates
Applicant	PHAMATECH INC. 9530 PADGETT ST., #101-106 SAN DIEGO, CA 92126 US Other 510(k) Applications for this Company
Contact	CARL MONGIOVI Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	DJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2001
Decision Date	12/06/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review