FDA 510(k) Application Details - K161714

Device Classification Name	Enzyme Immunoassay, Barbiturate   More FDA Info for this Device
510(K) Number	K161714
Device Name	Enzyme Immunoassay, Barbiturate
Applicant	IMMUNALYSIS CORPORATION 829 TOWNE CENTER DRIVE POMONA, CA 91767 US Other 510(k) Applications for this Company
Contact	JOSEPH GINETE 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	06/21/2016
Decision Date	10/14/2016
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