510(k) K935229 ยท DPG Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
OPUS DIGITOXIN
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Dec 22, 1993 |
| Received | Nov 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935229
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.