FDA 510(k) Application Details - K121065

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K121065
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	POLYMED THERAPEUTICS, INC 12828 DOE LANE GAITHERSBURG, MD 20878 US Other 510(k) Applications for this Company
Contact	JJ XIA 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	04/06/2012
Decision Date	05/24/2013
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