510(k) Report

Devices descending from K972696

9 later devices reach IL Test D-Dimer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090264Hemosil D-Dimer HS 500, ControlsInstrumentation Laboratory CO20101—
+1K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO20092—
+1K050544Hemosil D-Dimer HSInstrumentation Laboratory CO20050—
+1K050278Hemosil D-DimerInstrumentation Laboratory CO20051—
+1K032419Quantex D-DimerInstrumentation Laboratory CO20030—
+2K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO20230—
+2K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO20170—
+2K170314ACL AcuStarInstrumentation Laboratory CO20170—
+2K073042Hemosil D-DimerInstrumentation Laboratory20080—