510(k) Report

Devices descending from K071255

2 later devices reach Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170854HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO20171Class I
+2K243374HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co.20250—