K253722
- 510(k) number
- K253722
- Device name
- LIAISON PLEX Gastrointestinal Flex Assay
- Applicant
- Luminex Corporation IL · US
- Product code
- PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Ac
- Decision date
- 2026-05-19
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K253722.pdf
Official FDA record: K253722
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.