510(k) Report

Devices descending from K161837

2 later devices reach ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.202307
+1K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd.20190—