510(k) K040733 ยท MMI Immunoassay Method, Troponin Subunit
ELECSYS TROPONIN T STAT TEST
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 17, 2004 |
| Received | Mar 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040733
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.