510(k) Report

Devices descending from K062203

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112120Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories20130—