FDA 510(k) Application Details - K002272

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K002272
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	RAPHAEL WONG 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	07/26/2000
Decision Date	11/22/2000
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