510(k) DEN240080 ยท SFU Glucose Range Monitoring System
Biolinq Shine Autonomous Time-in-Range Microsensor
| Applicant | Biolinq Incorporated, San Diego CA, US |
| Decision | Unknown, Sep 23, 2025 |
| Received | Dec 27, 2024 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN240080
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.