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FDA 510(k)

Panther Fusion GI Expanded Bacterial Assay

K-Number: K251993 · 2025-09-25

ApplicantHologic, Inc.
Decision Date2025-09-25
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Panther Fusion GI Expanded Bacterial Assay is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2025-09-25 under approval number K251993. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panther Fusion GI Expanded Bacterial Assay?

Panther Fusion GI Expanded Bacterial Assay is a medical device that received FDA 510(k) clearance on 2025-09-25. It is manufactured by Hologic, Inc.. The 510(k) number is K251993.

When was Panther Fusion GI Expanded Bacterial Assay approved by the FDA?

Panther Fusion GI Expanded Bacterial Assay received FDA 510(k) clearance on 2025-09-25, under approval number K251993.

What company makes Panther Fusion GI Expanded Bacterial Assay?

Panther Fusion GI Expanded Bacterial Assay is manufactured by Hologic, Inc..

What is the FDA product code for Panther Fusion GI Expanded Bacterial Assay?

The FDA product code for Panther Fusion GI Expanded Bacterial Assay is PCH.

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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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