510(k) K963425 ยท KTN System, Test, Infectious Mononucleosis
GENZYME DIAGNOSTICS CONTRAST MONO
| Applicant | Genzyme Diagnostics, San Carlos CA, US |
| Decision | Substantially Equivalent, Feb 25, 1997 |
| Received | Aug 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963425
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.