De Novo
DEN160048: FilmArray NGDS Warrior Panel
FDA De Novo · biofire defense, llc · decided Feb 14, 2017
Key facts
| De Novo number | DEN160048 |
|---|---|
| Device name | FilmArray NGDS Warrior Panel |
| Applicant | biofire defense, llc |
| Product code | PRD |
| Date received | Oct 17, 2016 |
| Decision date | Feb 14, 2017 |
| Decision | granted (DENG) |
| FDA classification | Not classified |
| Review panel | Missing Review Panel |
| FEI number | 3010770794 |
At a glance
- 1–9 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: