510(k) Report

Devices descending from K983379

9 later devices reach Gti-PF4 Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053559PF4 Enhanced Solid Phase ElisaGenetic Testing Institute200662
+1K052697Heparin/Platelet Factor 4 Antibody Serum PanelAkers Biosciences, Inc.20060—
+1K040293Healthtest Heparin/Platelet Factor 4 Antibody AssayAkers Laboratories, Inc.20040—
+2K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc.20200—
+2K071781PF4 IGGGenetic Testing Institute20071—
+2K071255Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed200728
+3K201311PF4 IgG assayImmucor Gti Diagnostics, Inc.20200—
+3K170854HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO20171Class I
+4K243374HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co.20250—