510(k) Report

Devices descending from K984193

2 later devices reach Dimensions RXL Myoglobin (Myo) Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122599Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorSiemens Healthcare Diagnostics, Inc.201201
+1K053576Dimension Vista Myo Reagent Cartridge and CalibratorDade Behring, Inc.200601