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FDA 510(k)

QuickVue COVID-19 Test

K-Number: K231795 · 2024-03-22

ApplicantQuidel Corporation
Decision Date2024-03-22
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QuickVue COVID-19 Test is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K231795. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuickVue COVID-19 Test?

QuickVue COVID-19 Test is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Quidel Corporation. The 510(k) number is K231795.

When did QuickVue COVID-19 Test receive FDA 510(k) clearance?

QuickVue COVID-19 Test received FDA 510(k) clearance on 2024-03-22, under 510(k) number K231795.

Who is the listed applicant for QuickVue COVID-19 Test?

The FDA 510(k) record lists Quidel Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QuickVue COVID-19 Test?

The FDA product code for QuickVue COVID-19 Test is QYT.

Other records listing Quidel Corporation 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.

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Related Devices (Code: QYT)

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.

K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLCK260095Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLCK251916GenBody COVID-19 Ag Home TestGenbody.Inc.K251595COVID-19 Detect Rapid Self -TestInBios International, Inc.K251753GenaCheck COVID-19 Rapid Self-TestGenabio Diagnostics, Inc.K241313OHC COVID-19 Antigen Self TestOsang, LLC

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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