K243144
- 510(k) number
- K243144
- Device name
- X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
- Applicant
- Scopio Labs , Ltd. IL
- Product code
- JOY — Device, Automated Cell-Locating
- Decision date
- 2025-06-27
- Date received
- 2024-09-30
- 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: K243144.pdf
Official FDA record: K243144
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.