510(k) K000784 ยท MMI Immunoassay Method, Troponin Subunit
THE CARDIAC READER SYSTEM
| Applicant | Roche Diagnostics Corp., Great Neck, NY, US |
| Decision | Substantially Equivalent, May 18, 2000 |
| Received | Mar 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000784
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2005 | Roche Diagnostics Corp. Roche brand Cardiac Reader. Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.