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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K253971
Device Name Visby Medical Flu and COVID-19 Test
Applicant
Visby Medical, Inc.
3010 N. First St.
San Jose,  CA  95134
Applicant Contact Jennifer Albrecht
Correspondent
Visby Medical, Inc.
3010 N. First St.
San Jose,  CA  95134
Correspondent Contact Jennifer Albrecht
Classification Product Code
SIA
Date Received12/11/2025
Decision Date 05/27/2026
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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