FDA 510(k) Application Details - K193480

Device Classification Name	Test, Opiates, Over The Counter   More FDA Info for this Device
510(K) Number	K193480
Device Name	Test, Opiates, Over The Counter
Applicant	Shenzhen Bioeasy Biotechnology Co.,Ltd. No.2-1, Liuxian 1st Road, Xin'an Sub-District Shenzhen 518101 CN Other 510(k) Applications for this Company
Contact	Wenhau Yan 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	12/16/2019
Decision Date	01/31/2020
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