Panels › Clinical Chemistry › Product code SAF · Class 2
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Regulation 862.1355
1510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SAF
| Company | 510(k)s | Recalls |
|---|---|---|
| Dexcom, Inc. | 2 | 0 |
| Abbott | 1 | 0 |
| Signos, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 21, 2026 | K261359 | Stelo Glucose Biosensor System Dexcom, Inc. | SAF |
| Mar 21, 2025 | K250106 | Signos Glucose Monitoring System Signos, Inc. | SAF |
| May 29, 2024 | K233655 | Lingo Glucose System Abbott | SAF |
| Mar 5, 2024 | K234070 | Stelo Glucose Biosensor System Dexcom, Inc. | SAF |
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