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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 K181790
Device Name CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Applicant
Hangzhou Clongene Biotech Co., Ltd.
Bldg. 4, #20 Longquan Rd., Yuhang District
Hangzhou,  CN 311121
Applicant Contact Zheng Shujian
Correspondent
Lsi International
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Jesse Xia
Regulation Number862.3650
Classification Product Code
NGL  
Subsequent Product Codes
NGG   NGM   QAW  
Date Received07/05/2018
Decision Date 07/26/2018
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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