Source document or public record
FDA 510(k) K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
FDA 510(k) index record K213858. Device: LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus. Applicant as listed: DiaSorin, Inc.. Decision date: 2022-07-26.
Source
"device_name": "LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K213858.
Device name: LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus. Applicant as listed: DiaSorin, Inc..
Decision date: 2022-07-26. Decision wording: Substantially Equivalent.
Product code: NXO. Regulation: 21 CFR 866.5180. Medical specialty: Immunology.
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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