FDA 510(k)

Lyra Influenza A+B Assay

K-Number: K230236 · 2023-03-03

Decision Date2023-03-03

Product CodeOZE

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Lyra Influenza A+B Assay is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K230236. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lyra Influenza A+B Assay?

Lyra Influenza A+B Assay is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Quidel Corporation. The 510(k) number is K230236.

When did Lyra Influenza A+B Assay receive FDA 510(k) clearance?

Lyra Influenza A+B Assay received FDA 510(k) clearance on 2023-03-03, under 510(k) number K230236.

Who is the listed applicant for Lyra Influenza A+B Assay?

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 Lyra Influenza A+B Assay?

The FDA product code for Lyra Influenza A+B Assay is OZE.

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Related Devices (Code: OZE)

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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.