Minuteful-kidney test is an AI-enabled medical device from Healthy.io Ltd., listed by FDA (510(k), K222921) with a decision date of 2023-09-08. Review panel: Clinical Chemistry.
| FDA submission number | K222921 |
|---|---|
| Pathway | 510(k) |
| Company | Healthy.io Ltd. |
| Review panel (specialty) | Clinical Chemistry |
| FDA decision date | 2023-09-08 |
| Decision | Substantially Equivalent |
| Product code | JIR |
| Classification | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Device class | 1 |
| Regulation number | 862.1645 |
| Review time (calendar days) | 347 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
More devices from Healthy.io Ltd. · 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.