510(k) K914833 ยท DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
IMMULITE DIGOXIN
| Applicant | Cirrus Diagnostics, Inc., Chester NJ, US |
| Decision | Substantially Equivalent, Nov 22, 1991 |
| Received | Oct 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914833
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.