510(k) K905719 ยท DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
ECLIPSE ICA DIGOXIN
| Applicant | Biotope, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Jan 17, 1991 |
| Received | Dec 21, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905719
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.