Documento fuente o registro público

FDA 510(k) K192586 — LIAISON® Folate

FDA 510(k) index record K192586. Device: LIAISON® Folate. Applicant as listed: DiaSorin, Inc.. Decision date: 2020-05-06.

OtherU.S. Food and Drug Administration (FDA)2020-05-06

Fuente

"device_name": "LIAISON® Folate"

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 K192586.

Device name: LIAISON® Folate. Applicant as listed: DiaSorin, Inc..

Decision date: 2020-05-06. Decision wording: Substantially Equivalent.

Product code: CGN. Regulation: 21 CFR 862.1295. Medical specialty: Clinical Chemistry.

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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