510(k) K864449 ยท DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
| Applicant | Canadian Bioclinical, Ltd., Ontario Mix 1b4, CA |
| Decision | Substantially Equivalent, Feb 2, 1987 |
| Received | Nov 12, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864449
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.