510(k) K171566 ยท MMI Immunoassay Method, Troponin Subunit
Atellica IM High-Sensitivity Troponin I (TNIH)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 19, 2018 |
| Received | May 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171566
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.