510(k) K153301 ยท KXT Enzyme Immunoassay, Digoxin
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 8, 2016 |
| Received | Nov 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153301
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.