FDA 510(k) Application Details - K201630

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K201630
Device Name	Enzyme Immunoassay, Opiates
Applicant	Assure Tech (Hangzhou) Co., Ltd. 2nd-5th Floor, Building 4, No. 1418-50, Moganshan Road, Gongshu District Hangzhou 310011 CN Other 510(k) Applications for this Company
Contact	Shisheng Ling Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	DJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2020
Decision Date	08/12/2021
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