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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK240686
Test Name Healgen Scientific LLC, Healgen Accurate Urine Drug Screen Dip Card  
Manufacturer NameHealgen Scientific,, LLC
Consumer Information Phone Number1(866)982-3818
Test TypeMethadone metabolite (EDDP)
Effective Date04/23/2024
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.
504 E 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
Predetermined Change
Control Plan Authorized		 No
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