Documento fuente o registro público

FDA 510(k) K253722 — LIAISON PLEX Gastrointestinal Flex Assay

FDA 510(k) index record K253722. Device: LIAISON PLEX Gastrointestinal Flex Assay. Applicant as listed: Luminex Corporation. Decision date: 2026-05-19.

OtherU.S. Food and Drug Administration (FDA)2026-05-19

Fuente

"device_name": "LIAISON PLEX Gastrointestinal Flex Assay"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-22

Disclaimer

professional use

FDA 510(k) public index record K253722.

Device name: LIAISON PLEX Gastrointestinal Flex Assay. Applicant as listed: Luminex Corporation.

Decision date: 2026-05-19. Decision wording: Substantially Equivalent.

Product code: PCH. Regulation: 21 CFR 866.3990. Medical specialty: Microbiology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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