510(k) Report

Devices descending from K102157

9 later devices reach Elecsys Precicontrol Multimarker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+2K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+2K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+3K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+3K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+3K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+3K170938CalSet IGF-1Roche Diagnostics20170—
+3K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+4K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—