De Novo
DEN170045: Banyan BTI
FDA De Novo · banyan biomarkers, inc. · decided Feb 14, 2018
Key facts
| De Novo number | DEN170045 |
|---|---|
| Device name | Banyan BTI |
| Applicant | banyan biomarkers, inc. |
| Product code | QAT |
| Date received | Aug 28, 2017 |
| Decision date | Feb 14, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Immunology |
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: