510(k) K182225 ยท MMI Immunoassay Method, Troponin Subunit
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Mar 4, 2019 |
| Received | Aug 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma
Catalog Number K6427, SMN# 1 Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.