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FDA 510(k)

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

K-Number: K222736 · 2023-05-16

ApplicantHologic, Inc.
Decision Date2023-05-16
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 2023-05-16 under approval number K222736. 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 2023-05-16. It is manufactured by Hologic, Inc.. The 510(k) number is K222736.

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 2023-05-16, under approval number K222736.

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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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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