KidneyIntelX.dkd is an AI-enabled medical device from Renalytix AI, Inc., listed by FDA (De Novo, DEN200052) with a decision date of 2023-06-29. Review panel: Clinical Chemistry.
| FDA submission number | DEN200052 |
|---|---|
| Pathway | De Novo |
| Company | Renalytix AI, Inc. |
| Review panel (specialty) | Clinical Chemistry |
| FDA decision date | 2023-06-29 |
| Decision | Unknown |
| Product code | QWZ |
| Classification | Prognostic Test For Assessment Of Chronic Kidney Disease Progression |
| Device class | 2 |
| Regulation number | 862.1223 |
| Review time (calendar days) | 1037 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.