FDA 510(k) Application Details - K152643

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K152643
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	NANTONG EGENS BIOTECH CO., LTD. BUILDING 15, 1692 XINGHU AVENUE NANTONG 226010 CN Other 510(k) Applications for this Company
Contact	Yan Cao Other 510(k) Applications for this Contact
Regulation Number	862.3870   More FDA Info for this Regulation Number
Classification Product Code	LDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2015
Decision Date	11/02/2015
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