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FDA 510(k)

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay

K-Number: K242465 · 2024-11-15

ApplicantHologic, Inc.
Decision Date2024-11-15
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2024-11-15 under approval number K242465. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay?

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a medical device that received FDA 510(k) clearance on 2024-11-15. It is manufactured by Hologic, Inc.. The 510(k) number is K242465.

When was Panther Fusion SARS-CoV-2/Flu A/B/RSV assay approved by the FDA?

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay received FDA 510(k) clearance on 2024-11-15, under approval number K242465.

What company makes Panther Fusion SARS-CoV-2/Flu A/B/RSV assay?

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is manufactured by Hologic, Inc..

What is the FDA product code for Panther Fusion SARS-CoV-2/Flu A/B/RSV assay?

The FDA product code for Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is QOF.

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Related Devices (Code: QOF)

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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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