510(k) K162678 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 23, 2017 |
| Received | Sep 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162678
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.