FDA 510(k) Application Details - K012582

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K012582
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	AMEDITECH, INC. 10340 CAMINO SANTA FE SUITES F-G SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JOHN WU 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	08/10/2001
Decision Date	11/30/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review