510(k) K093441 ยท KXT Enzyme Immunoassay, Digoxin
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Apr 7, 2010 |
| Received | Nov 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093441
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Digoxin (DIGXN) Flex reagent cartridge Terminated |
KXT | None listed |
| Apr 18, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product. Terminated |
KXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.