510(k) K811776 ยท DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
KALLESTAD QUANTICOAT 125 DIGOXIN
| Applicant | Kallestad Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 10, 1981 |
| Received | Jun 23, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811776
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.