APAS Independence with Urine Analysis Module is an AI-enabled medical device from Clever Culture Systems AG, listed by FDA (510(k), K183648) with a decision date of 2019-05-15. Review panel: Microbiology.
| FDA submission number | K183648 |
|---|---|
| Pathway | 510(k) |
| Company | Clever Culture Systems AG |
| Review panel (specialty) | Microbiology |
| FDA decision date | 2019-05-15 |
| Decision | Substantially Equivalent |
| Product code | PPU |
| Classification | Microbial Colony Image Assessment System |
| Device class | 2 |
| Regulation number | 866.2190 |
| Review time (calendar days) | 140 |
| Applicant country | CH |
Official FDA database record · FDA AI-enabled device list
All Microbiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.