Yumizen H2500— 510(k) K232946

Name: FDA 510(k) clearance K232946
Creator: U.S. Food and Drug Administration
Published: 2024-05-21

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K232946 for Yumizen H2500, Substantially Equivalent on 2024-05-21. Applicant: HORIBA ABX SAS. Device class: 2.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2023-09-20
Decision date: 2024-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier, FR

Download summary PDF View on FDA.gov ↗

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K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer2025-06-25

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K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M2020-06-26
K192028 — Yumizen C1200 CRP2020-06-25
K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor2020-03-06
K191993 — Yumizen C1200 CRP2019-10-03

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.