FDA 510(k)

Visby Medical Flu and COVID-19 Test

K-Number: K253971 · 2026-05-27

Decision Date2026-05-27

Product CodeSIA

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Visby Medical Flu and COVID-19 Test is the device name listed in this FDA 510(k) record. The listed applicant is Visby Medical, Inc.. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K253971. The device is classified under product code SIA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visby Medical Flu and COVID-19 Test?

Visby Medical Flu and COVID-19 Test is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Visby Medical, Inc.. The 510(k) number is K253971.

When did Visby Medical Flu and COVID-19 Test receive FDA 510(k) clearance?

Visby Medical Flu and COVID-19 Test received FDA 510(k) clearance on 2026-05-27, under 510(k) number K253971.

Who is the listed applicant for Visby Medical Flu and COVID-19 Test?

The FDA 510(k) record lists Visby Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visby Medical Flu and COVID-19 Test?

The FDA product code for Visby Medical Flu and COVID-19 Test is SIA.

Other records listing Visby Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251501Visby Medical Men's Sexual Health Test K242526Visby Medical Respiratory Health Test K220407Visby Medical Sexual Health Test K200748Visby Medical Sexual Health

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.