510(k) Report

Devices descending from K013785

1 later device reach Urovysion Bladder Cancer Recurrence Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203245Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit…Nucleix, Ltd.20230—