FDA 510(k) Application Details - K070009

Device Classification Name	Enzyme Immunoassay, Barbiturate   More FDA Info for this Device
510(K) Number	K070009
Device Name	Enzyme Immunoassay, Barbiturate
Applicant	PHAMATECH INC. 10151 BARNES CANYON RD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	CARL MONGIOVI Other 510(k) Applications for this Contact
Regulation Number	862.3150   More FDA Info for this Regulation Number
Classification Product Code	DIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2007
Decision Date	12/07/2007
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