510(k) K253817 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La
| Applicant | Immunodiagnostics Systems Limited, Boldon, GB |
| Decision | Substantially Equivalent, Aug 21, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253817
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.