FDA 510(k) Application Details - K080431

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K080431
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	QUANTRX BIOMEDICAL CORPORATION 13721 VIA TRES VISTA SAN DIEGO, CA 92129 US Other 510(k) Applications for this Company
Contact	NATALIE J KENNEL 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	02/19/2008
Decision Date	01/08/2009
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