510(k) Report

Devices descending from K945642

11 later devices reach Agen Dimertest Gold Eia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974776Mda D-DimerOrganon Teknika Corp.19980—
+1K972696IL Test D-DimerInstrumentation Laboratory CO19979—
+2K090264Hemosil D-Dimer HS 500, ControlsInstrumentation Laboratory CO20101—
+2K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO20092—
+2K050544Hemosil D-Dimer HSInstrumentation Laboratory CO20050—
+2K050278Hemosil D-DimerInstrumentation Laboratory CO20051—
+2K032419Quantex D-DimerInstrumentation Laboratory CO20030—
+3K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO20230—
+3K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO20170—
+3K170314ACL AcuStarInstrumentation Laboratory CO20170—
+3K073042Hemosil D-DimerInstrumentation Laboratory20080—