510(k) K183648 ยท PPU Microbial Colony Image Assessment System
APAS Independence with Urine Analysis Module
| Applicant | Clever Culture Systems AG, Bach, CH |
| Decision | Substantially Equivalent, May 15, 2019 |
| Received | Dec 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183648
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.