510(k) Report

Devices descending from K860894

44 later devices reach Behring Nephelometer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082503Dimension Vista LG Light Chains, Type Kappa, Dimension Vista LG Light Chains, Type…Siemens Healthcare Diagnostics200801
+1K063608Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…Dade Behring, Inc.20071—
+1K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…Dade Behring, Inc.20066—
+1K053072N Antisera to Human ALPHA1-AntitrypsinDade Behring, Inc.20068—
+1K053073N Antisera to Human ALPHA2-MacroglobulinDade Behring, Inc.20061—
+1K053074N Antisera to Human CeruloplasminDade Behring, Inc.20062—
+1K050596Quantia A1-atBiokit, S.A.20050—
+1K050665N Antisera to Human Complement Factors (C3C, C4)Dade Behring, Inc.20051—
+1K042735N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Dade Behring, Inc.200510—
+1K042521Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1…Ortho-Clinical Diagnostics, Inc.20040—
+1K042475Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator…Ortho-Clinical Diagnostics, Inc.20040—
+1K042494Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…Ortho-Clinical Diagnostics20040—
+1K013249Tina-Quant Apolipoprotein Ver.2Roche Diagnostics Corp.200101
+1K013206Tina-Quant Apolipoprotein B Ver.2Roche Diagnostics Corp.20010—
+1K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc.199712
+1K961824Cobas Integra Reagent Cassettes for Albumin, Hbalc and DigoxinRoche Diagnostic Systems, Inc.19961—
+1K962523N Latex CRP Mono ReagentBehring Diagnostics, Inc.19967—
+2K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings20180—
+2K161508CeruloplasminBeckman Coulter Ireland, Inc.20170—
+2K090594Dimension Vista Immunoglobulin a Flex Reagent Cartridge (Iga), and Dimension Vista…Siemens Healthcare Diagnostics20090—
+2K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics200912
+2K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080—
+2K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080—
+2K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.20081—
+2K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…Dade Behring, Inc.20076—
+2K063655Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…Dade Behring, Inc.20070—
+2K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc.20075—
+2K063610Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium…Dade Behring, Inc.20070—
+2K061852Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low…Dade Behring, Inc.20060—
+2K061845Dimension Vista Igm Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and HDade Behring, Inc.20060—
+2K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc.20067—
+2K060853Online TDM TobramycinRoche Diagnostics Corp.200602
+2K990992Integra Reagent Cassette for Hemoglobin AlcRoche Diagnostics Corp.19990—
+2K990825Revised C-Reactive Protein (RCRP) Flex Reagent CartridgeDade Behring, Inc.19990—
+2K981638Immage Immunochemistry System C-Reactive Protein (CRP) ReagentBeckman Coulter, Inc.199841
+2K964687N Latex CRP Mono ReagentBehring Diagnostics, Inc.19960—
+3K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH20230—
+3K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc.20074—
+3K071980Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,HDade Behring, Inc.20072—
+3K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc.20066—
+3K050836CRP Diagnostic AssaySentinel Ch. Srl20051—
+3K022690Paros CRPHoriba, Ltd.20020—
+3K990704Array 360 System C-Reactive Protein (CRP Mpe) ReagentBeckman Coulter, Inc.19990—
+4K192118CRP VarioSENTINEL CH. SpA20190—