De Novo
DEN240032: APO-Easy Genotyping kit
FDA De Novo · firalis sa · decided Jun 12, 2025
Key facts
| De Novo number | DEN240032 |
|---|---|
| Device name | APO-Easy Genotyping kit |
| Applicant | firalis sa |
| Product code | SFC |
| Date received | Jun 21, 2024 |
| Decision date | Jun 12, 2025 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Immunology |
| FEI number | 3009523773 |
At a glance
- None Later 510(k)s citing this De Novo
- None 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: