510(k) K202067 ยท LKP Anti-Sm Antibody, Antigen And Control
EliA SmDP-S
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Jul 14, 2021 |
| Received | Jul 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202067
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.