Panels › Clinical Chemistry › Product code QBJ · Class 2
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Regulation 862.1355
3510(k)s in 12 months (18 all time)
5recalls in 12 months (23 all time)
16recalls that name a 510(k)
Top companies in QBJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Dexcom, Inc. | 15 | 20 |
| Abbott Diabetes Care, Inc. | 3 | 0 |
| Cardinal Health Inc. | 0 | 1 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Medtronic Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 8, 2026 | K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Feb 3, 2026 | K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QBJ |
| Dec 17, 2025 | K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QBJ |
| Apr 9, 2025 | K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Apr 23, 2024 | K240902 | Dexcom G7 Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Apr 23, 2024 | K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc. | QBJ |
| Feb 26, 2024 | K234133 | Dexcom G7 Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| May 15, 2023 | K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QBJ |
| Apr 13, 2023 | K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc. | QBJ |
| Mar 3, 2023 | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care, Inc. | QBJ |
| Jan 11, 2023 | K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QBJ |
| Dec 7, 2022 | K213919 | Dexcom G7 Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Jul 29, 2022 | K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) Syst Dexcom, Inc. | QBJ |
| Jul 15, 2021 | K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QBJ |
| Dec 4, 2020 | K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Jun 28, 2019 | K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexco Dexcom, Inc. | QBJ |
| Feb 14, 2019 | K183206 | Dexcom G6 Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Mar 27, 2018 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
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