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510(k) K253971

Visby Medical Flu and COVID-19 Test by Visby Medical, Inc. — Product Code SIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2026
Date Received
December 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Visby Medical, Inc.

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  • DEN240020 — Visby Medical Women's Sexual Health Test (March 28, 2025)
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  • K220407 — Visby Medical Sexual Health Test (March 7, 2023)
  • K200748 — Visby Medical Sexual Health (August 26, 2021)