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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Opiates, Over The Counter
510(k) Number K242802
Device Name CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
Applicant
Hangzhou Clongene Biotech Co., Ltd.
#1 Yichuang Rd., Yuhang District
Hangzhou,  CN 311121
Applicant Contact Frank Zheng
Correspondent
LSI International, Inc.
504e Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Regulation Number862.3650
Classification Product Code
NGL  
Date Received09/17/2024
Decision Date 11/08/2024
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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