510(k) Report

Devices descending from K011143

4 later devices reach Tina-Quant D-Dimer Test System through their predicates, nearest generation first.

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