510(k) K780475 ยท DON Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT
| Applicant | Burroughs Wellcome Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 24, 1978 |
| Received | Mar 24, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780475
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.