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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Cannabinoid, Over The Counter
510(k) Number K252523
Device Name Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
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 Number862.3870
Classification Product Code
NFW  
Subsequent Product Code
MKU  
Date Received08/11/2025
Decision Date 02/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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