K240402
- 510(k) number
- K240402
- Device name
- Cito CBC System
- Applicant
- Cytochip, Inc. CA · US
- Product code
- GKZ — Counter, Differential Cell
- Decision date
- 2025-02-03
- Date received
- 2024-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240402.pdf
Official FDA record: K240402
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.