510(k) K192524 ยท MOI System, Test, Immunological, Antigen, Tumor
Lumipulse G CA15-3
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Sep 4, 2020 |
| Received | Sep 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192524
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.