510(k) Report

Devices descending from K100831

3 later devices reach Cyfra 21-1 Eia Model 211-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202852DiviTum TKaBiovica International AB20220—
+1K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics20161—
+2K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc.20250—