FDA 510(k) Application Details - K101059

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K101059
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	OMEGA LABORATORIES, INC. PO BOX 506 SOUTH LYON, MI 48178 US Other 510(k) Applications for this Company
Contact	ROBERT J BARD 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	04/15/2010
Decision Date	07/12/2010
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