510(k) K183007 ยท LKP Anti-Sm Antibody, Antigen And Control
EliA SmDP Immunoassay
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Dec 24, 2018 |
| Received | Oct 31, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183007
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.