FDA 510(k) Application Details - K122759

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K122759
Device Name	Enzyme Immunoassay, Cannabinoids
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	862.3870   More FDA Info for this Regulation Number
Classification Product Code	LDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2012
Decision Date	12/05/2012
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