LIAISON PLEX Gastrointestinal Flex Assay— 510(k) K253722

Name: FDA 510(k) clearance K253722
Creator: U.S. Food and Drug Administration
Published: 2026-05-19

Substantially Equivalent

Luminex Corporation

FDA 510(k) clearance K253722 for LIAISON PLEX Gastrointestinal Flex Assay, Substantially Equivalent on 2026-05-19. Applicant: Luminex Corporation. Device class: 2.

Clearance details

Applicant: Luminex Corporation
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2025-11-24
Decision date: 2026-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.