510(k) K221693 ยท MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Elecsys Anti-HCV II (08837031190)
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 4, 2023 |
| Received | Jun 10, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221693
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.