510(k) K082699 ยท MMI Immunoassay Method, Troponin Subunit
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 19, 2009 |
| Received | Sep 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082699
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2021 | Roche Diagnostics Operations, Inc. Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. Open, Classified |
MMI | None listed |
| Apr 7, 2021 | Roche Diagnostics Operations, Inc. Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. Open, Classified |
MMI | None listed |
| Apr 11, 2012 | Roche Diagnostics Operations, Inc. Elecsys Troponin I Immunoassay
For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarc Terminated |
MMI | None listed |
| Apr 11, 2012 | Roche Diagnostics Operations, Inc. Elecsys Troponin I STAT Immunoassay
For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial i Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.