FDA 510(k) Application Details - K010564

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K010564
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. BURLINGTON, NC 27215 US Other 510(k) Applications for this Company
Contact	MICHAEL TURANCHIK 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	02/26/2001
Decision Date	04/05/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review