510(k) Report

Devices descending from K003767

4 later devices reach Asserachrom Hpia Test Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153137HemosIL HIT-Ab (PF4-H), HemosIL HIT-Ab (PF4-H) ControlsInstrumentation Laboratory CO20160—
+1K071255Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed200728
+2K170854HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO20171Class I
+3K243374HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co.20250—