510(k) Report

Devices descending from K053108

2 later devices reach Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061503Dimension Cyclosporine Extended Range Calibrator (DC108A)Dade Behring, Inc.20061—
+2K082030Dimension Vista Csae Calibrator, Model KC440Siemens Healthcare Diagnostics, Inc.20080—