FDA 510(k) Application Details - K063699

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K063699
Device Name	Enzyme Immunoassay, Opiates
Applicant	NOVX SYSTEMS INC. 16809 BRIARDALE ROAD ROCKVILLE, MD 20853 US Other 510(k) Applications for this Company
Contact	THOMAS TSAKERIS 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	12/13/2006
Decision Date	06/01/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review