510(k) Report

Devices descending from K002609

9 later devices reach Tina-Quant Rheumatoid Factors II Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032535Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp.20037—
+1K024067Rheumatoid Factor (RF)Abbott Laboratories20030—
+2K062035Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and ControlDade 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—
+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—