510(k) Report

Devices descending from K993706

5 later devices reach Elecsys Serum B-Crosslaps/Serum Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051543Elecsys Precicontrol BoneRoche Diagnostics Corp.20054—
+2K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+3K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+4K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+4K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—