510(k) K781674 ยท DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
MACRO-VUE TEST, GENTAMICIN
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Washington DC, US |
| Decision | Substantially Equivalent, Nov 15, 1978 |
| Received | Oct 3, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K781674
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.