FDA 510(k) Application Details - K973726

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K973726
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	APPLIED TECHNOLOGY VENTURES, L.L.C. 2190 FOX MILL RD., STE. 200 HERNDON, VA 20171 US Other 510(k) Applications for this Company
Contact	RICHARD ROBLIN 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	09/30/1997
Decision Date	11/06/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review