510(k) K874678 ยท KTN System, Test, Infectious Mononucleosis
I.M.N. LATEX
| Applicant | Biokit USA, Inc., Barcelona, Spain, US |
| Decision | Substantially Equivalent, Dec 14, 1987 |
| Received | Nov 13, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874678
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.