FDA 510(k) Application Details - K153646

Device Classification Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites   More FDA Info for this Device
510(K) Number	K153646
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant	SAFECARE BIOTECH (HANGZHOU)CO.,LTD. BUILDING 2/203 NO.18 HAISHU RD., CANGQIAN SUB-DISTRICT, YUHANG DISTRICT HANGZHOU 311121 CN Other 510(k) Applications for this Company
Contact	Alex Qiu Other 510(k) Applications for this Contact
Regulation Number	862.3250   More FDA Info for this Regulation Number
Classification Product Code	DIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2015
Decision Date	03/18/2016
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