De Novo
DEN240025: VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
FDA De Novo · ventana medical systems, inc. · decided Dec 5, 2024
Key facts
| De Novo number | DEN240025 |
|---|---|
| Device name | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) |
| Applicant | ventana medical systems, inc. |
| Product code | SDP |
| Date received | May 29, 2024 |
| Decision date | Dec 5, 2024 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Medical Genetics |
| FEI number | 1000125183 |
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: