510(k) K200811 ยท LKM Counter, Urine Particle
cobas u 701 microscopy analyzer
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 6, 2020 |
| Received | Mar 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200811
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.