510(k) K921012 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Cockeysville MD, US |
| Decision | Substantially Equivalent, Apr 8, 1992 |
| Received | Mar 3, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921012
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.