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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Covid-19 Antigen Test
510(k) Number K260095
Device Name Heal-Check Rapid COVID-19 Antigen Self-Test
Applicant
Healgen Scientific,, LLC
3818 Fuqua St.
Houston,  TX  77047
Applicant Contact Bingliang Fang
Correspondent
Healgen Scientific,, LLC
3818 Fuqua St.
Houston,  TX  77047
Correspondent Contact Dung Nguyen
Classification Product Code
QYT  
Date Received01/13/2026
Decision Date 04/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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