510(k) Report

Devices descending from K964635

4 later devices reach Nichols Advantage Chemiluminescence Calcitonin Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023304Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLDiagnostic Products Corp.200231
+2K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+3K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+3K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—