510(k) Report

Devices descending from K050029

2 later devices reach Cardiompo Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071474Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge, Calibrator,Control…Siemens Healthcare Diagnostics20080—
+1K062840Triage Protein C Controls and Calibration Verification ControlsBiosite Incorporated20070—