510(k) K053020 ยท MMI Immunoassay Method, Troponin Subunit
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 30, 2005 |
| Received | Oct 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2016 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac trop Terminated |
MMI | None listed |
| Jul 23, 2015 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests
Product Usage:
For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, Terminated |
MMI | None listed |
| Jul 2, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790 Terminated |
MMI | None listed |
| Jun 5, 2008 | Siemens Medical Solutions Diagnostics ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, T Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.