510(k) K853144 ยท KTN System, Test, Infectious Mononucleosis
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036
| Applicant | Preco, Inc., Oakland NJ, US |
| Decision | Substantially Equivalent, Oct 16, 1985 |
| Received | Jul 29, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853144
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.