Source document or public record
FDA 510(k) K260781 — Yumizen H550
FDA 510(k) index record K260781. Device: Yumizen H550. Applicant as listed: HORIBA ABX SAS. Decision date: 2026-09-14.
Source
"device_name": "Yumizen H550"
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
professional use
FDA 510(k) public index record K260781.
Device name: Yumizen H550. Applicant as listed: HORIBA ABX SAS.
Decision date: 2026-09-14. Decision wording: Substantially Equivalent.
Product code: GKZ. Regulation: 21 CFR 864.5220. Medical specialty: Hematology.
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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