510(k) K895765 ยท KTN System, Test, Infectious Mononucleosis
LEECO PREVIEW(R) EBV (EIA)
| Applicant | Leeco Diagnostics, Inc., Southfield MI, US |
| Decision | Substantially Equivalent, Oct 31, 1989 |
| Received | Sep 26, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895765
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.