510(k) DEN250049 ยท SJD Integrated Continuous Glucose Ketone Monitoring System
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
| Applicant | Abbott Diabetes Care, Alameda CA, US |
| Decision | Unknown, Aug 25, 2026 |
| Received | Sep 29, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250049
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.