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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 the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2025-09-25 under 510(k) 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. The listed applicant is Hologic, Inc.. The 510(k) number is K251993.

When did Panther Fusion GI Expanded Bacterial Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for Panther Fusion GI Expanded Bacterial 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 GI Expanded Bacterial Assay?

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

Related Clinical Trials

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Related Devices (Code: PCH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex CorporationK254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251721Xpert GI PanelCepheidK252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251868Panther Fusion GI Bacterial AssayHologicK250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH

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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