FDA 510(k) Application Details - K142044

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K142044
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG, MD 20878 US Other 510(k) Applications for this Company
Contact	Joe Shia 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	07/28/2014
Decision Date	08/25/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review