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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 K251753
Device Name GenaCheck COVID-19 Rapid Self-Test
Applicant
Genabio Diagnostics, Inc.
19 Crosby Dr. Suite 220
Bedford,  MA  01730
Applicant Contact Han Si
Correspondent
Genabio Diagnostics, Inc.
19 Crosby Dr. Suite 220
Bedford,  MA  01730
Correspondent Contact Han Si
Classification Product Code
QYT  
Date Received06/09/2025
Decision Date 09/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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