510(k) K896926 ยท KTN System, Test, Infectious Mononucleosis
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 26, 1990 |
| Received | Dec 11, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896926
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.