Yumizen H550— 510(k) K260781
Substantially EquivalentHORIBA ABX SAS
FDA 510(k) clearance K260781 for Yumizen H550, Substantially Equivalent on 2026-09-14. Applicant: HORIBA ABX SAS. Device class: 2.
Summary
Yumizen H550 is from HORIBA ABX SAS, filed under product code GKZ (Counter, Differential Cell). The record gives the model name and nothing else about the instrument.
Class II, 21 CFR 864.5220. Hematology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
HORIBA filed from Montpellier, France. The decision came 188 calendar days after receipt (March 10 to September 14, 2026).
Clearance details
- Applicant
- HORIBA ABX SAS
- Product code
- Product code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montpellier, FR
Recent devices under product code GKZ
view allMore clearances from HORIBA ABX SAS
view allAdverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . 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.