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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Methamphetamine
510(k) Number K240287
Device Name LYHER® Oral fluid Multi-Drug Test Kit (Cube)
Applicant
Hangzhou Laihe Biotech Co., Ltd.
Rm. 401-406, F1-3, Bldg. 1, #425 Miaohouwang Rd.
Sixing St., Binjiang District
Hangzhou,  CN 310051
Applicant Contact Chen Yaohua
Correspondent
Shanghai Thinkwell Consulting Co., Ltd.
Xinling Rd., 211/6f
Shanghai,  CN 201100
Correspondent Contact Ethan Liu
Regulation Number862.3610
Classification Product Code
DJC  
Subsequent Product Codes
DIO   DJG   DKZ   LCM   LDJ  
Date Received02/01/2024
Decision Date 03/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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