De Novo
DEN240067: KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
FDA De Novo · cytocell limited · decided Sep 19, 2025
Key facts
| De Novo number | DEN240067 |
|---|---|
| Device name | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) |
| Applicant | cytocell limited |
| Product code | SFS |
| Date received | Nov 22, 2024 |
| Decision date | Sep 19, 2025 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Pathology |
| FEI number | 3002646096 |
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: