510(k) Report

Devices descending from K070927

8 later devices reach Hemosil D-Dimer HS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151534HemosIL D-Dimer HSInstrumentation Laboratory CO20151—
+1K090264Hemosil D-Dimer HS 500, ControlsInstrumentation Laboratory CO20101—
+1K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO20092—
+1K073042Hemosil D-DimerInstrumentation Laboratory20080—
+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—
+2K160885HemosIL D-Dimer HSInstrumentation Laboratory CO20160—