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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K253722
Device Name LIAISON PLEX Gastrointestinal Flex Assay
Applicant
Luminex Corporation
4088 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact Michael Treas
Correspondent
Luminex Corporation
4088 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact Michael Treas
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Code
NSU  
Date Received11/24/2025
Decision Date 05/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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