510(k) K260049 ยท SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Elecsys Anti-HBc IgM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 7, 2026 |
| Received | Jan 7, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260049
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.