FDA 510(k) Application Details - K011163

Device Classification Name	Enzyme Immunoassay, Propoxyphene   More FDA Info for this Device
510(K) Number	K011163
Device Name	Enzyme Immunoassay, Propoxyphene
Applicant	SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. SAN JOSE, CA 95135 US Other 510(k) Applications for this Company
Contact	SUSAN COLLINS 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	04/16/2001
Decision Date	05/10/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review