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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 K243365
Device Name Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
Applicant
Healgen Scientific, LLC
3818 Fuqua St.,
Houston,  TX  77047
Applicant Contact Jianqiu Fang
Correspondent
LSI International, Inc.
504e Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Regulation Number862.3650
Classification Product Code
NGL  
Subsequent Product Codes
NFT   NFV   NFW   NFY   NGG  
NGM   PTG   PTH   QAW   QBF  
Date Received10/29/2024
Decision Date 12/17/2024
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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