510(k) K890991 ยท KTN System, Test, Infectious Mononucleosis
MONO-CUBE(TM)
| Applicant | Difco Laboratories, Inc., Detroit MI, US |
| Decision | Substantially Equivalent, Mar 16, 1989 |
| Received | Feb 27, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890991
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.