510(k) K974244 ยท LSE Epstein-Barr Virus, Other
IMMUNODOT MONO-M TEST
| Applicant | Genbio, San Diego CA, US |
| Decision | Substantially Equivalent, Sep 22, 1998 |
| Received | Nov 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974244
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.