FDA 510(k) Application Details - K080057

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K080057
Device Name	Enzyme Immunoassay, Amphetamine
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	862.3100   More FDA Info for this Regulation Number
Classification Product Code	DKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/09/2008
Decision Date	10/31/2008
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