510(k) Report

Devices descending from K042735

10 later devices reach N Antisera to Human Immunoglobulins (Igg, Iga and Igm) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090594Dimension Vista Immunoglobulin a Flex Reagent Cartridge (Iga), and Dimension Vista…Siemens Healthcare Diagnostics20090—
+1K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics200912
+1K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080—
+1K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.20081—
+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—
+2K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH20230—
+2K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc.20066—
+3K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc.20075—
+4K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc.20074—