510(k) K780075 ยท DPG Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
RIALYZE DIGOXIN
| Applicant | Miles Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 28, 1978 |
| Received | Jan 16, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780075
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.