510(k) K880577 ยท JHI Visual, Pregnancy Hcg, Prescription Use
CONCEP-7-BHCG
| Applicant | Leeco Diagnostics, Inc., Southfield MI, US |
| Decision | Substantially Equivalent, Mar 15, 1988 |
| Received | Feb 10, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880577
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.