510(k) K894793 ยท KTN System, Test, Infectious Mononucleosis
MONODEX
| Applicant | Cenogenics Corp., Morganville NJ, US |
| Decision | Substantially Equivalent, Aug 21, 1989 |
| Received | Jul 28, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894793
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.