FDA 510(k)

Solana RSV+hMPV Assay

K-Number: K171974 · 2017-10-16

Decision Date2017-10-16

Product CodeOCC

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Solana RSV+hMPV Assay is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2017-10-16 under approval number K171974. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solana RSV+hMPV Assay?

Solana RSV+hMPV Assay is a medical device that received FDA 510(k) clearance on 2017-10-16. It is manufactured by Quidel Corporation. The 510(k) number is K171974.

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

Solana RSV+hMPV Assay received FDA 510(k) clearance on 2017-10-16, under approval number K171974.

What company makes Solana RSV+hMPV Assay?

Solana RSV+hMPV Assay is manufactured by Quidel Corporation.

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

The FDA product code for Solana RSV+hMPV Assay is OCC.

Other Devices by Quidel Corporation

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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.