510(k) K894975 ยท KTN System, Test, Infectious Mononucleosis
IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST
| Applicant | General Biometrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 13, 1989 |
| Received | Aug 7, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894975
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.