510(k) K063756 ยท MMI Immunoassay Method, Troponin Subunit
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Mar 19, 2007 |
| Received | Dec 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063756
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridge Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.