510(k) K844289 ยท KTN System, Test, Infectious Mononucleosis
SERIES I/S INFECTIONS
| Applicant | American Dade, Santa Ana CA, US |
| Decision | Substantially Equivalent, Nov 19, 1984 |
| Received | Nov 5, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K844289
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.