FDA 510(k) Application Details - K140671

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K140671
Device Name	Enzyme Immunoassay, Opiates
Applicant	OMEGA LABORATORIES, INC. 400 NORTH CLEVELAND MOGADORE, OH 44260 US Other 510(k) Applications for this Company
Contact	ROBERT J BARD 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	03/18/2014
Decision Date	01/08/2015
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