FDA.report

510(k) K253722

Device
LIAISON PLEX Gastrointestinal Flex Assay
Applicant
Luminex Corporation
510(k) number
K253722
Product code
PCH
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-19
Date received
2025-11-24
Regulation
866.3990
Classification name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Michael Treas
Address
4088 Commercial Ave. Northbrook IL US 60062 60062

FDA Registration Numbers

Source Documents

510(k) summary PDF

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