FDA 510(k) Application Details - K232228

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K232228
Device Name	Enzyme Immunoassay, Opiates
Applicant	Shanghai Accurature Diagnostics Co., Ltd. Building 1,No.168 Banqiao East Road,Shanyang Town Jinshan District,Shanghai 201508,P.R.China Shanghai CN Other 510(k) Applications for this Company
Contact	Shuang He 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	07/27/2023
Decision Date	02/23/2024
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