510(k) Report

Devices descending from K083518

2 later devices reach Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO20230—
+1K170314ACL AcuStarInstrumentation Laboratory CO20170—