510(k) K160910 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Elecsys Syphilis
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 28, 2016 |
| Received | Apr 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160910
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.