510(k) Report

Devices descending from K951013

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073490Olympus Igg ReagentOlympus America, Inc.20083—
+2K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas20200—
+2K162208DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc.20171—
+3K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.20230—