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FDA 510(k)

Visby Medical Respiratory Health Test

K-Number: K242526 · 2025-02-19

ApplicantVisby Medical, Inc.
Decision Date2025-02-19
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Visby Medical Respiratory Health 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 2025-02-19 under 510(k) number K242526. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visby Medical Respiratory Health Test?

Visby Medical Respiratory Health Test is a medical device that received FDA 510(k) clearance on 2025-02-19. The listed applicant is Visby Medical, Inc.. The 510(k) number is K242526.

When did Visby Medical Respiratory Health Test receive FDA 510(k) clearance?

Visby Medical Respiratory Health Test received FDA 510(k) clearance on 2025-02-19, under 510(k) number K242526.

Who is the listed applicant for Visby Medical Respiratory Health 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 Respiratory Health Test?

The FDA product code for Visby Medical Respiratory Health Test is QOF.

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.

K253971Visby Medical Flu and COVID-19 TestK251501Visby Medical Men's Sexual Health TestK220407Visby Medical Sexual Health TestK200748Visby Medical Sexual Health

Related Devices (Code: QOF)

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.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH

Official Source

View on FDA Database →

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

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