FDA Product Code
FDA Product Code QDK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1355
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203089 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021-08-17 | Traditional | PDF ↗ |
| K193642 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2020-01-29 | Special | PDF ↗ |
| K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System | Dexcom, Inc. | 2019-10-25 | Special | PDF ↗ |
| K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2018-10-26 | Traditional | PDF ↗ |
Product code QDK · Class II · Clinical Chemistry. Data: openFDA.