ACR LAB Urine Analysis Test System is an AI-enabled medical device from Healthy.io Ltd, listed by FDA (510(k), K182384) with a decision date of 2019-07-26. Review panel: Clinical Chemistry.
| FDA submission number | K182384 |
|---|---|
| Pathway | 510(k) |
| Company | Healthy.io Ltd |
| Review panel (specialty) | Clinical Chemistry |
| FDA decision date | 2019-07-26 |
| Decision | Substantially Equivalent |
| Product code | JFY |
| Classification | Enzymatic Method, Creatinine |
| Device class | 2 |
| Regulation number | 862.1225 |
| Review time (calendar days) | 329 |
| Applicant country | IL |
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.