De Novo
DEN250049: Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
FDA De Novo · abbott diabetes care · decided Aug 25, 2026
Key facts
| De Novo number | DEN250049 |
|---|---|
| Device name | Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System |
| Applicant | abbott diabetes care |
| Product code | SJD |
| Date received | Sep 29, 2025 |
| Decision date | Aug 25, 2026 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
| FEI number | 3002803444 |
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: