510(k) K033007 ยท KXT Enzyme Immunoassay, Digoxin
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Nov 14, 2003 |
| Received | Sep 26, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033007
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.