Documento fuente o registro público

FDA 510(k) K193001 — Albumin BCP

FDA 510(k) index record K193001. Device: Albumin BCP. Applicant as listed: SENTINEL CH. SpA. Decision date: 2019-12-19.

OtherU.S. Food and Drug Administration (FDA)2019-12-19

Fuente

"device_name": "Albumin BCP"
api.fda.gov · Consultado el 2026-10-19

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

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Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

References

FDA 510(k) public index record K193001.

Device name: Albumin BCP. Applicant as listed: SENTINEL CH. SpA.

Decision date: 2019-12-19. Decision wording: Substantially Equivalent.

Product code: CJW. Regulation: 21 CFR 862.1035. 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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FDA 510(k) K193001 — Albumin BCP

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