FDA Product Code
FDA Product Code QCC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1358
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232722 | endo.digital Platform | DreaMed Diabetes, Ltd. | 2023-10-03 | Special | PDF ↗ |
| K210561 | Advisor Pro Platform | DreaMed Diabetes, Ltd. | 2021-09-28 | Traditional | PDF ↗ |
| K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020-08-28 | Traditional | PDF ↗ |
| K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019-07-18 | Traditional | PDF ↗ |
| DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018-06-12 | Direct | — |
Product code QCC · Class II · Clinical Chemistry. Data: openFDA.