De Novo
DEN170047: Curetis Unyvero LRT Application
FDA De Novo · curetis gmbh · decided Apr 3, 2018
Key facts
| De Novo number | DEN170047 |
|---|---|
| Device name | Curetis Unyvero LRT Application |
| Applicant | curetis gmbh |
| Product code | QBH |
| Date received | Sep 11, 2017 |
| Decision date | Apr 3, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 3014470579 |
At a glance
- 1–9 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: