510(k) K210902 ยท LKJ Antinuclear Antibody, Antigen, Control
EliA Ro52, EliA Ro60
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Jul 27, 2022 |
| Received | Mar 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210902
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.