510(k) K211181 ยท PZJ Lynch Syndrome Test System
Idylla MSI Test
| Applicant | Biocartis NV, Mechelen, BE |
| Decision | Substantially Equivalent, Feb 27, 2023 |
| Received | Apr 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211181
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.