510(k) K991795 ยท MMI Immunoassay Method, Troponin Subunit
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Jun 9, 1999 |
| Received | May 26, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2014 | Siemens Healthcare Diagnostics, Inc. Turbo Troponin I
For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI). Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.