510(k) Report

Devices descending from K113546

8 later devices reach Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+1K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+2K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+2K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+2K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+2K170938CalSet IGF-1Roche Diagnostics20170—
+2K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+3K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—