FDA 510(k) Application Details - K242428

Device Classification Name	Test, Opiates, Over The Counter   More FDA Info for this Device
510(K) Number	K242428
Device Name	Test, Opiates, Over The Counter
Applicant	Guangzhou Decheng Biotechnology Co., Ltd. Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road Science City, Huangpu District Guangzhou 510663 CN Other 510(k) Applications for this Company
Contact	Jenny Mao 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	08/15/2024
Decision Date	02/06/2025
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