510(k) K840822 ยท KTN System, Test, Infectious Mononucleosis
LEAP MONO TEST KIT
| Applicant | Cooper Biomedical, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Apr 5, 1984 |
| Received | Feb 24, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840822
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.