K230887
- 510(k) number
- K230887
- Device name
- Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
- Applicant
- Sysmex America, Inc. IL · US
- Product code
- GKZ — Counter, Differential Cell
- Decision date
- 2023-12-21
- Date received
- 2023-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230887.pdf
Official FDA record: K230887
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.