510(k) Report

Devices descending from K972235

3 later devices reach Precicontrol Tumor Marker 1 and 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050387Roche Diagnostics Elecsys Precicontrol TumorRoche Diagnostics Corp.20052—
+2K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics20161—
+3K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc.20250—