510(k) K213348 ยท PZJ Lynch Syndrome Test System
BOND MMR Antibody Panel
| Applicant | Leica Biosystems Newcastle, Ltd., Newcastle Upon Tyne, GB |
| Decision | Substantially Equivalent, Feb 21, 2023 |
| Received | Oct 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213348
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.