510(k) Report

Devices descending from K132828

2 later devices reach Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+1K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—