Documento fuente o registro público

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.

OtherU.S. Food and Drug Administration (FDA)2022-12-22

Fuente

"device_name": "Lp(a) Ultra"
api.fda.gov · Consultado el 2026-10-29

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

2026-10-30

Disclaimer

professional use

References

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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FDA 510(k) K211058 — Lp(a) Ultra

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