De Novo
DEN200052: KidneyIntelX.dkd
FDA De Novo · renalytix ai, inc. · decided Jun 29, 2023
Key facts
| De Novo number | DEN200052 |
|---|---|
| Device name | KidneyIntelX.dkd |
| Applicant | renalytix ai, inc. |
| Product code | QWZ |
| Date received | Aug 26, 2020 |
| Decision date | Jun 29, 2023 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
| FEI number | 3018739912 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: