510(k) K203245 ยท MMW System, Test, Tumor Marker, Monitoring, Bladder
Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
| Applicant | Nucleix , Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, May 4, 2023 |
| Received | Nov 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203245
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.