510(k) K211302 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Elecsys Syphilis
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 20, 2021 |
| Received | Apr 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211302
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.