510(k) K853388 ยท KTN System, Test, Infectious Mononucleosis
MONOSTICON UNI-DOT
| Applicant | Organon, Inc., West Orange NJ, US |
| Decision | Substantially Equivalent, Aug 22, 1985 |
| Received | Aug 13, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853388
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.