Skip to contentDe Novo DEN230034
- Device
- X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
- Contact
- shahar karny
- De Novo number
- DEN230034
- Product code
- SAL
- Regulation
- 864.5261
- Classification name
- device, automated cell locating, bone marrow
- Decision
- granted (DENG)
- Decision date
- 2024-03-22
- Date received
- 2023-04-28
- Classification advisory
- Hematology
- Review advisory
- Hematology
- Type
- Direct
Current FDA Classification#
- Product code
- SAL
- Device name
- Device, Automated Cell Locating, Bone Marrow
- Medical specialty
- Hematology
- Device class
- 2
- Regulation
- 864.5261
- Implant
- N
- Life sustain/support
- N