510(k) K864591 ยท JHI Visual, Pregnancy Hcg, Prescription Use
HCG SOLID PHASE COMPONENT SYSTEM
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Feb 4, 1987 |
| Received | Nov 21, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864591
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.