FDA 510(k) Application Details - K140665

Device Classification Name	Enzyme Immunoassay, Barbiturate   More FDA Info for this Device
510(K) Number	K140665
Device Name	Enzyme Immunoassay, Barbiturate
Applicant	GENPRIME, INC 502 W. Riversude, Suite 101 Spokane, WA 99201 US Other 510(k) Applications for this Company
Contact	Darby McLean 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	03/18/2014
Decision Date	12/08/2014
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