FDA 510(k) Application Details - K012390

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K012390
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	DRUG FREE ENTERPRISES 1627 S GRANVILLE AVE. SUITE 3 WEST LOS ANGELES, CA 90025 US Other 510(k) Applications for this Company
Contact	PERRY RUCKER 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	07/27/2001
Decision Date	12/18/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review