510(k) K984105 ยท MMI Immunoassay Method, Troponin Subunit
ELECSYS TROPONIN T STAT TEST
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 8, 1998 |
| Received | Nov 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984105
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2006 | Roche Diagnostics Corp. Roche brand Elecsys Troponin T; catalog number 2017644. Terminated |
MMI | None listed |
| May 29, 2003 | Roche Diagnostics Corp. Elecsys Troponin T; catalog number 2017644 Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.