FDA 510(k) Application Details - K043303

Device Classification Name	Enzyme Immunoassay, Propoxyphene   More FDA Info for this Device
510(K) Number	K043303
Device Name	Enzyme Immunoassay, Propoxyphene
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	KERWIN KAUFMAN 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	11/30/2004
Decision Date	03/11/2005
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