510(k) Report

Devices descending from K073490

3 later devices reach Olympus Igg Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas20200—
+1K162208DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc.20171—
+2K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.20230—