FDA 510(k) Application Details - K020254

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K020254
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	Lin-Zhi International, Inc. 2391 ZANKER RD. SUITE 340 SAN JOSE, CA 95131 US Other 510(k) Applications for this Company
Contact	CHIU CHIN CHANG Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	LCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2002
Decision Date	05/10/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review