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FDA 510(k)

Lyra Influenza A+B Assay

K-Number: K230236 · 2023-03-03

ApplicantQuidel Corporation
Decision Date2023-03-03
Product CodeOZE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Lyra Influenza A+B Assay is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2023-03-03 under approval 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. It is manufactured by Quidel Corporation. The 510(k) number is K230236.

When was Lyra Influenza A+B Assay approved by the FDA?

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

What company makes Lyra Influenza A+B Assay?

Lyra Influenza A+B Assay is manufactured by Quidel Corporation.

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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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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