510(k) K893737 ยท KTN System, Test, Infectious Mononucleosis
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 16, 1989 |
| Received | May 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893737
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.