510(k) Report

Devices descending from K160915

1 later device reach Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc.20250—