Documento fuente o registro público

FDA 510(k) K240627 — LIAISON PLEX Yeast Blood Culture Assay

FDA 510(k) index record K240627. Device: LIAISON PLEX Yeast Blood Culture Assay. Applicant as listed: Luminex Corporation. Decision date: 2024-06-04.

OtherU.S. Food and Drug Administration (FDA)2024-06-04

Fuente

"device_name": "LIAISON PLEX Yeast Blood Culture 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

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K240627.

Device name: LIAISON PLEX Yeast Blood Culture Assay. Applicant as listed: Luminex Corporation.

Decision date: 2024-06-04. Decision wording: Substantially Equivalent.

Product code: PEO. Regulation: 21 CFR 866.3365. 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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