FDA 510(k) Application Details - K181790

Device Classification Name	Test, Opiates, Over The Counter   More FDA Info for this Device
510(K) Number	K181790
Device Name	Test, Opiates, Over The Counter
Applicant	Hangzhou Clongene Biotech Co.,Ltd. Building 4, No.20 Longquan Road, Yuhang District Hangzhou 311121 CN Other 510(k) Applications for this Company
Contact	Zheng Shujian Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	NGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2018
Decision Date	07/26/2018
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