510(k) K980521 ยท KXT Enzyme Immunoassay, Digoxin
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Apr 2, 1998 |
| Received | Jan 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980521
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.