FDA 510(k) Application Details - K232597

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K232597
Device Name	Enzyme Immunoassay, Opiates
Applicant	Hangzhou Laihe Biotech Co., Ltd. Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road Xixing Street, Binjiang District Hangzhou 310051 CN Other 510(k) Applications for this Company
Contact	Yaohua Chen 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	08/28/2023
Decision Date	01/09/2024
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