510(k) K260233 ยท LJN Antibody Igm, If, Epstein-Barr Virus
Elecsys EBV IgM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 2, 2026 |
| Received | Jan 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260233
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.