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FDA 510(k)

LIAISON PLEX Gastrointestinal Flex Assay

K-Number: K253722 · 2026-05-19

ApplicantLuminex Corporation
Decision Date2026-05-19
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON PLEX Gastrointestinal Flex Assay is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2026-05-19 under 510(k) number K253722. 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 LIAISON PLEX Gastrointestinal Flex Assay?

LIAISON PLEX Gastrointestinal Flex Assay is a medical device that received FDA 510(k) clearance on 2026-05-19. The listed applicant is Luminex Corporation. The 510(k) number is K253722.

When did LIAISON PLEX Gastrointestinal Flex Assay receive FDA 510(k) clearance?

LIAISON PLEX Gastrointestinal Flex Assay received FDA 510(k) clearance on 2026-05-19, under 510(k) number K253722.

Who is the listed applicant for LIAISON PLEX Gastrointestinal Flex Assay?

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

What is the FDA product code for LIAISON PLEX Gastrointestinal Flex Assay?

The FDA product code for LIAISON PLEX Gastrointestinal Flex Assay is PCH.

Other records listing Luminex Corporation as applicant

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.

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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.

K254032QIAstat-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 GmbHK251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.K251868Panther 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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