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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cannabinoids
510(k) Number K232604
Device Name LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
Applicant
Hangzhou Laihe Biotech Co., Ltd.
Rm. 401-406, F1-3, Bldg. 1, #425 Miaohouwang Rd.
Xixing St., Binjiang District
Hangzhou,  CN 310051
Applicant Contact Yaohua Chen
Correspondent
Shanghai Thinkwell Consulting Co., Ltd.
Xinling Rd., 211/6f
Shanghai,  CN 201100
Correspondent Contact Ethan Liu
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received08/28/2023
Decision Date 01/10/2024
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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