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FDA 510(k)

Lyra RSV+hMPV Assay

K-Number: K230349 · 2023-03-10

ApplicantQuidel Corporation
Decision Date2023-03-10
Product CodeOEM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Lyra RSV+hMPV Assay is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2023-03-10 under approval number K230349. The device is classified under product code OEM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lyra RSV+hMPV Assay?

Lyra RSV+hMPV Assay is a medical device that received FDA 510(k) clearance on 2023-03-10. It is manufactured by Quidel Corporation. The 510(k) number is K230349.

When was Lyra RSV+hMPV Assay approved by the FDA?

Lyra RSV+hMPV Assay received FDA 510(k) clearance on 2023-03-10, under approval number K230349.

What company makes Lyra RSV+hMPV Assay?

Lyra RSV+hMPV Assay is manufactured by Quidel Corporation.

What is the FDA product code for Lyra RSV+hMPV Assay?

The FDA product code for Lyra RSV+hMPV Assay is OEM.

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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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