510(k) K863933 ยท JHI Visual, Pregnancy Hcg, Prescription Use
VIS-CUBE HCG (EIA)
| Applicant | Leeco Diagnostics, Inc., Southfield MI, US |
| Decision | Substantially Equivalent, Dec 15, 1986 |
| Received | Oct 8, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863933
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.