K240636
- 510(k) number
- K240636
- Device name
- HemoScreen Hematology Analyzer
- Applicant
- Pixcell Medical Technologies IL
- Product code
- GKZ — Counter, Differential Cell
- Decision date
- 2024-05-02
- Date received
- 2024-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K240636.pdf
Official FDA record: K240636
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.