FDA 510(k) Application Details - K041221

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K041221
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	ACCU-STAT DIAGNOSTICS, INC. 11 ORCHARD RD., SUITE 108 LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	JAMES G BARRONS 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	05/10/2004
Decision Date	07/13/2004
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