FDA 510(k) Application Details - K023795

Device Classification Name	Enzyme Immunoassay, Propoxyphene   More FDA Info for this Device
510(K) Number	K023795
Device Name	Enzyme Immunoassay, Propoxyphene
Applicant	Lin-Zhi International, Inc. 2391 ZANKER RD., SUITE 340 SAN JOSE, CA 95131-1124 US Other 510(k) Applications for this Company
Contact	CHIU CHIN CHANG 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	11/13/2002
Decision Date	01/21/2003
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