De Novo DEN250049
- Device
- Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
- Contact
- katherine doll kanne
- De Novo number
- DEN250049
- Product code
- SJD
- Regulation
- 862.1354
- Classification name
- integrated continuous glucose ketone monitoring system
- Decision
- granted (DENG)
- Decision date
- 2026-08-25
- Date received
- 2025-09-29
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct