510(k) Report

Devices descending from K053559

6 later devices reach PF4 Enhanced Solid Phase Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc.20200—
+1K071781PF4 IGGGenetic Testing Institute20071—
+1K071255Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed200728
+2K201311PF4 IgG assayImmucor Gti Diagnostics, Inc.20200—
+2K170854HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO20171Class I
+3K243374HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co.20250—