Panels › Clinical Chemistry › Product code SBH · Class 2
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
Regulation 862.1355
2510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SBH
| Company | 510(k)s | Recalls |
|---|---|---|
| Dexcom, Inc. | 2 | 0 |
| Abbott Diabetes Care | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2026 | K262472 | Stelo Glucose Biosensor System Dexcom, Inc. | SBH |
| Jun 12, 2026 | K260935 | Stelo Glucose Biosensor System Dexcom, Inc. | SBH |
| Jun 7, 2024 | K233861 | Libre Rio Continuous Glucose Monitoring System Abbott Diabetes Care | SBH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.