K232946
- 510(k) number
- K232946
- Device name
- Yumizen H2500
- Applicant
- HORIBA ABX SAS FR
- Product code
- GKZ — Counter, Differential Cell
- Decision date
- 2024-05-21
- Date received
- 2023-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232946.pdf
Official FDA record: K232946
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.