510(k) Report

Devices descending from K053157

2 later devices reach Automated HDL Cholesterol Flex Reagent Cartridge, Model DF48A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.200617
+2K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics201502