510(k) Report

Devices descending from K170854

1 later device reach HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243374HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co.20250—