510(k) K182353 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Nov 27, 2018 |
| Received | Aug 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182353
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.