FDA 510(k) Application Details - K000400

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K000400
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	DRUG DETECTION DEVICES, LTD. 6820 MEADOWRIDGE COURT SUITE A-7 ALPHARETTA, GA 30005 US Other 510(k) Applications for this Company
Contact	PATRICK BEENTJEES 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	02/07/2000
Decision Date	04/18/2000
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