510(k) Report

Devices descending from K984191

2 later devices reach Myoglobin Flex Reagent Cartridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053576Dimension Vista Myo Reagent Cartridge and CalibratorDade Behring, Inc.200601
+1K033300Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range VerifiersOrtho-Clinical Diagnostics, Inc.200301