FDA 510(k) Application Details - K231904

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K231904
Device Name	Enzyme Immunoassay, Opiates
Applicant	Co-Innovation Biotech Co.,Ltd. No.9 Baihe 3 Street, Economic And Technological Development East Zone, Guangzhou 510530 CN Other 510(k) Applications for this Company
Contact	Hong Feng 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	06/28/2023
Decision Date	03/08/2024
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