FDA Product Code
FDA Product Code QBJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1355
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | 2026-06-08 | Traditional | PDF ↗ |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2026-02-03 | Traditional | PDF ↗ |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2025-12-17 | Special | PDF ↗ |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | 2025-04-09 | Traditional | PDF ↗ |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2024-04-23 | Traditional | PDF ↗ |
| K240902 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2024-04-23 | Special | PDF ↗ |
| K234133 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2024-02-26 | Traditional | PDF ↗ |
| K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023-05-15 | Special | PDF ↗ |
| K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2023-04-13 | Traditional | PDF ↗ |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2023-03-03 | Traditional | PDF ↗ |
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023-01-11 | Special | PDF ↗ |
| K213919 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2022-12-07 | Traditional | PDF ↗ |
| K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2022-07-29 | Special | PDF ↗ |
| K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021-07-15 | Traditional | PDF ↗ |
| K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2020-12-04 | Traditional | PDF ↗ |
| K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System | Dexcom, Inc. | 2019-06-28 | Special | PDF ↗ |
| K183206 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2019-02-14 | Traditional | PDF ↗ |
| DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018-03-27 | Direct | — |
Product code QBJ · Class II · Clinical Chemistry. Data: openFDA.