510(k) K051752 ยท MMI Immunoassay Method, Troponin Subunit
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 11, 2005 |
| Received | Jun 29, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051752
| 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.