510(k) K200129 ยท PZJ Lynch Syndrome Test System
OncoMate MSI Dx Analysis System
| Applicant | Promega Corporation, Madison WI, US |
| Decision | Substantially Equivalent, Jul 26, 2021 |
| Received | Jan 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200129
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.