FDA 510(k) Application Details - K232659

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K232659
Device Name	Enzyme Immunoassay, Opiates
Applicant	Guangzhou Decheng Biotechnology Co., Ltd. Room 107/218/212/405, Building 2, No. 68, 1st Nanxiang Road, Science City, Huangpu District Guangzhou 510000 CN Other 510(k) Applications for this Company
Contact	Weifang Liu 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	08/31/2023
Decision Date	12/13/2023
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