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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK253567
Test Name Medical Disposables, MD Urine Drug Screen Dip Card  
Manufacturer NameHealgen Scientific,, LLC
Consumer Information Phone Number1(888)863-1112
Test TypeOxazepam
Effective Date06/04/2026
Device Classification Name Test, Opiates, Over The Counter
510(k) Number K253567
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  77074
Applicant Contact Fang Jianqiu
Correspondent
LSI International, Inc.
504 E 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 Received11/17/2025
Decision Date 12/23/2025
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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