510(k) K023058 ยท KXT Enzyme Immunoassay, Digoxin
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
| Applicant | Seradyn, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 24, 2002 |
| Received | Sep 13, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023058
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.