510(k) DEN260027 ยท SJM
Elecsys HBsAg II quant II RxDx
| Applicant | Roche Diagnostics, Indianapolis IL, US |
| Decision | Unknown, Oct 20, 2026 |
| Received | Jun 2, 2026 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN260027
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.