510(k) Report

Devices descending from K943997

5 later devices reach Behring Nephelometer II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050113Tina-Quant Igg Gen.2Roche Diagnostics Corp.20054—
+2K073490Olympus Igg ReagentOlympus America, Inc.20083—
+3K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas20200—
+3K162208DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc.20171—
+4K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.20230—