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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Methamphetamine
510(k) Number K253705
Device Name Healgen® Accurate Oral Fluid Drug Test
Applicant
Healgen Scientific,, LLC
3818 Fuqua St.
Houston,  TX  77047
Applicant Contact Fang Jianqiu
Correspondent
LSI International, Inc.
504 E Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Xia Jenny
Regulation Number862.3610
Classification Product Code
DJC  
Subsequent Product Codes
DIO   DJG   DJR   DKZ   LCM  
LDJ  
Date Received11/24/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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