510(k) Report

Devices descending from K972788

7 later devices reach Crosslaps Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990843Serum Crosslaps One Step ElisaOsteometer Biotech A/S19996—
+2K993706Elecsys Serum B-Crosslaps/Serum ImmunoassayRoche Diagnostics Corp.200051
+3K051543Elecsys Precicontrol BoneRoche Diagnostics Corp.20054—
+4K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+5K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+6K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+6K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—