510(k) Report

Devices descending from K162840

4 later devices reach Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+1K170938CalSet IGF-1Roche Diagnostics20170—
+1K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+2K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—