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FDA 510(k)

Panther Fusion AdV/hMPV/RV Assay

K-Number: K231017 · 2023-05-05

ApplicantHologic, Inc.
Decision Date2023-05-05
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Panther Fusion AdV/hMPV/RV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K231017. 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 Panther Fusion AdV/hMPV/RV Assay?

Panther Fusion AdV/hMPV/RV Assay is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Hologic, Inc.. The 510(k) number is K231017.

When did Panther Fusion AdV/hMPV/RV Assay receive FDA 510(k) clearance?

Panther Fusion AdV/hMPV/RV Assay received FDA 510(k) clearance on 2023-05-05, under 510(k) number K231017.

Who is the listed applicant for Panther Fusion AdV/hMPV/RV Assay?

The FDA 510(k) record lists Hologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Panther Fusion AdV/hMPV/RV Assay?

The FDA product code for Panther Fusion AdV/hMPV/RV Assay is OCC.

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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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