510(k) K190773 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Elecsys TSH
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 16, 2019 |
| Received | Mar 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190773
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.