Dario Blood Glucose Monitoring System is an AI-enabled medical device from LabStyle Innovations Ltd., listed by FDA (510(k), K150817) with a decision date of 2015-12-21. Review panel: Clinical Chemistry.
| FDA submission number | K150817 |
|---|---|
| Pathway | 510(k) |
| Company | LabStyle Innovations Ltd. |
| Review panel (specialty) | Clinical Chemistry |
| FDA decision date | 2015-12-21 |
| Decision | Substantially Equivalent |
| Product code | NBW |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Device class | 2 |
| Regulation number | 862.1345 |
| Review time (calendar days) | 269 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Clinical Chemistry AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.