Source document or public record
FDA 510(k) K211058 — Lp(a) Ultra
FDA 510(k) index record K211058. Device: Lp(a) Ultra. Applicant as listed: SENTINEL CH. SpA. Decision date: 2022-12-22.
Source
"device_name": "Lp(a) Ultra"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K211058.
Device name: Lp(a) Ultra. Applicant as listed: SENTINEL CH. SpA.
Decision date: 2022-12-22. Decision wording: Substantially Equivalent.
Product code: DFC. Regulation: 21 CFR 866.5600. 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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