510(k) K932250 ยท KXT Enzyme Immunoassay, Digoxin
VIDAS DIGOXIN (DIG)
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Sep 10, 1993 |
| Received | May 10, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932250
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.