510(k) K193397 · KXT Enzyme Immunoassay, Digoxin
ADVIA Centaur® Digoxin assay
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 16, 2021 |
| Received | Dec 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193397
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.