510(k) Report

Devices descending from K111506

3 later devices reach Elecsys Precicontrol Varia 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+2K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+2K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—