FDA 510(k) Application Details - K152025

Device Classification Name	Enzyme Immunoassay, Methadone   More FDA Info for this Device
510(K) Number	K152025
Device Name	Enzyme Immunoassay, Methadone
Applicant	ASSURE TECH. CO., LTD. 2ND. FLOOR, BUILDING 1, NO. 10, XIYUANSAN ROAD HANGZHOU 310030 CN Other 510(k) Applications for this Company
Contact	ERIC LIN Other 510(k) Applications for this Contact
Regulation Number	862.3620   More FDA Info for this Regulation Number
Classification Product Code	DJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2015
Decision Date	10/05/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review