510(k) K961024 ยท KTN System, Test, Infectious Mononucleosis
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Mar 14, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961024
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.