K253212
- 510(k) number
- K253212
- Device name
- XR-Series (XR-10, XR-20) Automated Hematology Analyzers
- Applicant
- Sysmex America, Inc. IL · US
- Product code
- GKZ — Counter, Differential Cell
- Decision date
- 2026-05-27
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253212.pdf
Official FDA record: K253212
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.