510(k) K241165 · MMI Immunoassay Method, Troponin Subunit
Atellica® IM High-Sensitivity Troponin I (TnIH)
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 25, 2024 |
| Received | Apr 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241165
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.