510(k) Report

Devices descending from K011112

5 later devices reach Cyclosporine Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062199Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - KC430)Dade Behring, Inc.20060—
+1K052015Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108Dade Behring, Inc.20053—
+2K061503Dimension Cyclosporine Extended Range Calibrator (DC108A)Dade Behring, Inc.20061—
+2K053108Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108Dade Behring, Inc.20062—
+3K082030Dimension Vista Csae Calibrator, Model KC440Siemens Healthcare Diagnostics, Inc.20080—