Source document or public record
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.
Source
"device_name": "Albumin BCP"
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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2026-10-20
2026-10-20
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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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