510(k) K012901 ยท KTN System, Test, Infectious Mononucleosis
COLOR-MONOGEN
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Sep 27, 2001 |
| Received | Aug 29, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012901
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.