510(k) Report

Devices descending from K162208

1 later device reach DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.20230—