510(k) Report

Devices descending from K002706

5 later devices reach Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070453Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033…Olympus Life & Material Science Europa GmbH (Irish20070—
+1K033491Roche Diagnostics Cardiac D-Dimer Rapid Assay; Roche Diagnostics Cardiac D-Dimer ControlsRoche Diagnostics Corp.20040—
+1K030740Modification to Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp.20033—
+2K062203Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp.200711
+3K112120Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories20130—