510(k) K190675 ยท MMI Immunoassay Method, Troponin Subunit
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 17, 2019 |
| Received | Mar 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190675
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension LOCI 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: RF627, 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.