510(k) Report

Devices descending from K990843

6 later devices reach Serum Crosslaps One Step Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993706Elecsys Serum B-Crosslaps/Serum ImmunoassayRoche Diagnostics Corp.200051
+2K051543Elecsys Precicontrol BoneRoche Diagnostics Corp.20054—
+3K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+4K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+5K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+5K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—