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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 K251916
Device Name GenBody COVID-19 Ag Home Test
Applicant
Genbody.Inc.
3-18, Eopseong 2-Gil, Seobuk-Gu, Cheonan-Si
Chungcheongnam-Do
Cheonan-Si,  KR 31077
Applicant Contact Han-bum Park
Correspondent
Genbody.Inc.
3-18, Eopseong 2-Gil, Seobuk-Gu, Cheonan-Si
Chungcheongnam-Do
Cheonan-Si,  KR 31077
Correspondent Contact Han-bum Park
Classification Product Code
QYT  
Date Received06/23/2025
Decision Date 03/13/2026
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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