510(k) K220924 ยท MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Elecsys HSV-2 IgG (08948887160)
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 12, 2022 |
| Received | Mar 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220924
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.