FDA 510(k) Application Details - K130082

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K130082
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	GENPRIME, INC 1983 HAZELWOOD ROAD TOMS RIVER, NJ 08753 US Other 510(k) Applications for this Company
Contact	Maureen Garner 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	01/14/2013
Decision Date	12/20/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review