FDA 510(k) Application Details - K020787

Device Classification Name	Enzyme Immunoassay, Propoxyphene   More FDA Info for this Device
510(K) Number	K020787
Device Name	Enzyme Immunoassay, Propoxyphene
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	862.3700   More FDA Info for this Regulation Number
Classification Product Code	JXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2002
Decision Date	05/02/2002
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