510(k) Report

Devices descending from K863840

7 later devices reach Meth. & Cali. for the Dimension Clini/Chem. System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123677Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)Siemens Healthcare Diagnostics201301
+1K123320Dimension Ammonia Flex Reagent CartridgeSiemens Healthcare Diagnostics201303
+1K062316Dimension Vista Ammonia (Amon) Flex Reagent CartridgeDade Behring, Inc.20060—
+1K062152Creatinine Kinase MB Isoenzyme Verifier, Model DC27Dade Behring, Inc.20060—
+1K994114Dimension Total Iron Binding Capacity (Ibct) CalibratorDade Behring, Inc.20002—
+2K061251Dimension Vista Total Iron Binding Capacity CalibratorDade Behring, Inc.20060—
+2K052867Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc.200501