510(k) K193313 ยท JZO System, Test, Thyroid Autoantibody
Elecsys Anti-TSHR
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 27, 2020 |
| Received | Nov 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193313
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2026 | Roche Diagnostics Operations, Inc. The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretre Open, Classified |
JZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.