510(k) K260048 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Elecsys Anti-HAV IgM
| Applicant | Roche Diagnostics, Indianapolis IL, US |
| Decision | Substantially Equivalent, Apr 7, 2026 |
| Received | Jan 7, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260048
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.