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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, opiates
510(k) Number K232597
Device Name LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
Applicant
Hangzhou Laihe Biotech Co., Ltd.
Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road
Xixing Street, 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 Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DJC   DKZ   LCM   LDJ  
Date Received08/28/2023
Decision Date 01/09/2024
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
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