FDA 510(k) Application Details - K131110

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K131110
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	CO-INNOVATION BIOTECH CO., LTD. NO. 13 YANYUAN ROAD. TIANHE DISTRICT GUANGZHOU, GUANGDONG 510507 CN Other 510(k) Applications for this Company
Contact	HONG FENG Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	DKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2013
Decision Date	01/15/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review