510(k) Report

Devices descending from K030740

3 later devices reach Modification to Tina-Quant D-Dimer Test System 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—
+1K062203Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp.200711
+2K112120Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories20130—