FDA 510(k) Application Details - K240287

Device Classification Name	Thin Layer Chromatography, Metamphetamine   More FDA Info for this Device
510(K) Number	K240287
Device Name	Thin Layer Chromatography, Metamphetamine
Applicant	Hangzhou Laihe Biotech Co., Ltd. Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road Sixing Street, Binjiang District Hangzhou 310051 CN Other 510(k) Applications for this Company
Contact	Chen Yaohua Other 510(k) Applications for this Contact
Regulation Number	862.3610   More FDA Info for this Regulation Number
Classification Product Code	DJC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2024
Decision Date	03/18/2025
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