De Novo
DEN230034: X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
FDA De Novo · scopio labs ltd. · decided Mar 22, 2024
Key facts
| De Novo 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. |
| Product code | SAL |
| Date received | Apr 28, 2023 |
| Decision date | Mar 22, 2024 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Hematology |
| FEI number | 3018182832 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: