510(k) K861354 ยท CEP Radioimmunoassay, Luteinizing Hormone
RIGHT-DAY OVULATION HOME TEST
| Applicant | Leeco Diagnostics, Inc., Southfield MI, US |
| Decision | Substantially Equivalent, Sep 16, 1986 |
| Received | Apr 10, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861354
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.