510(k) K811421 ยท JHI Visual, Pregnancy Hcg, Prescription Use
HCG RADIOIMMUNOASSAY KIT (125I)
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Walker MI, US |
| Decision | Substantially Equivalent, Jul 10, 1981 |
| Received | May 20, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811421
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.