510(k) Report

Devices descending from K955858

10 later devices reach N/T Protein Control SY/L, M and H through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991704N/T Protein Control LCDade Behring, Inc.19999—
+2K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…Dade Behring, Inc.20066—
+2K032237N/T Protein ControlDade Behring, Inc.20031—
+3K081299Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1…Siemens Healthcare Diagnostics, Inc.20080—
+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—
+5K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics200912
+5K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.20081—
+6K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH20230—
+6K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080—