FDA 510(k) Application Details - K023317

Device Classification Name	Enzyme Immunoassay, Methadone   More FDA Info for this Device
510(K) Number	K023317
Device Name	Enzyme Immunoassay, Methadone
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	862.3620   More FDA Info for this Regulation Number
Classification Product Code	DJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2002
Decision Date	12/12/2002
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