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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 K240686
Device Name Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
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 Joe Shia
Regulation Number862.3650
Classification Product Code
NGL  
Subsequent Product Codes
NFT   NFV   NFW   NFY   NGG  
NGM   PTG   PTH   QAW   QBF  
Date Received03/12/2024
Decision Date 04/12/2024
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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