510(k) Report

Devices descending from K012468

26 later devices reach Modification to N/T Protein Control SL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082503Dimension Vista LG Light Chains, Type Kappa, Dimension Vista LG Light Chains, Type…Siemens Healthcare Diagnostics200801
+1K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080—
+1K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…Dade Behring, Inc.20076—
+1K063655Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…Dade Behring, Inc.20070—
+1K063425Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…Dade Behring, Inc.20070—
+1K063272Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium…Dade Behring, Inc.20070—
+1K063322Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control…Dade Behring, Inc.20070—
+1K063610Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium…Dade Behring, Inc.20070—
+1K063206Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control…Dade Behring, Inc.200613
+1K061852Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low…Dade Behring, Inc.20060—
+1K061845Dimension Vista Igm Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and HDade Behring, Inc.20060—
+1K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc.20067—
+1K051087Dimension Vista Integrated SystemDade Behring, Inc.2005532
+1K042475Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator…Ortho-Clinical Diagnostics, Inc.20040—
+2K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics201505
+2K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.20081—
+2K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc.20074—
+2K071980Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,HDade Behring, Inc.20072—
+2K062105Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories20070—
+2K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc.200613
+2K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc.20066—
+3K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics201502
+3K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics200912
+3K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080—
+3K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc.20075—
+4K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH20230—