DIP/U.S. Urine Analysis Test System is an AI-enabled medical device from Healthy.io Ltd, listed by FDA (510(k), K173327) with a decision date of 2018-07-18. Review panel: Clinical Chemistry.
| FDA submission number | K173327 |
|---|---|
| Pathway | 510(k) |
| Company | Healthy.io Ltd |
| Review panel (specialty) | Clinical Chemistry |
| FDA decision date | 2018-07-18 |
| Decision | Substantially Equivalent |
| Product code | JIL |
| Classification | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
| Device class | 2 |
| Regulation number | 862.1340 |
| Review time (calendar days) | 271 |
| 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.