DEN230034
- 510(k) number
- DEN230034
- Device name
- X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
- Applicant
- Scopio Labs , Ltd. IL
- Product code
- SAL — Device, Automated Cell Locating, Bone Marrow
- Decision date
- 2024-03-22
- Date received
- 2023-04-28
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Hematology
Official FDA record: DEN230034
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.