510(k) K901045 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, Mar 29, 1990 |
| Received | Mar 6, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901045
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.