FDA 510(k) Application Details - K112808

Device Classification Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites   More FDA Info for this Device
510(K) Number	K112808
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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	862.3250   More FDA Info for this Regulation Number
Classification Product Code	DIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2011
Decision Date	01/23/2012
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