510(k) K925183 ยท KTN System, Test, Infectious Mononucleosis
BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST
| Applicant | Princeton Biomedix, Princeton NJ, US |
| Decision | Substantially Equivalent, Feb 23, 1993 |
| Received | Oct 14, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925183
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.