510(k) K081643 ยท MMI Immunoassay Method, Troponin Subunit
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Jul 3, 2008 |
| Received | Jun 12, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205 Terminated |
MMI | None listed |
| May 5, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Troponin 1 (TNI) Flex reagent cartridge Terminated |
MMI | None listed |
| Oct 19, 2011 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges Terminated |
JJE | None listed |
| Nov 24, 2010 | Siemens Healthcare Diagnostics, Inc. The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE. Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.