FDA 510(k) Application Details - K993981

Device Classification Name	Enzyme Immunoassay, Propoxyphene   More FDA Info for this Device
510(K) Number	K993981
Device Name	Enzyme Immunoassay, Propoxyphene
Applicant	SYVA CO. 3403 YERBA BUENA RD. SAN JOSE, CA 95161-9013 US Other 510(k) Applications for this Company
Contact	PAUL L ROGERS 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	11/24/1999
Decision Date	02/01/2000
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