510(k) K853105 ยท KTN System, Test, Infectious Mononucleosis
IMMUNO-IM
| Applicant | Immunostics Co., Inc., Metuchen NJ, US |
| Decision | Substantially Equivalent, Sep 3, 1985 |
| Received | Jul 23, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853105
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.