510(k) K253367 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
EliA CTD 13 Screen
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Jun 25, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253367
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.