510(k) K972457 ยท KTN System, Test, Infectious Mononucleosis
MONOCOL/LEX-IM TEST
| Applicant | Immunostics Inc.,, Ocean NJ, US |
| Decision | Substantially Equivalent, Dec 1, 1997 |
| Received | Jul 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972457
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.