510(k) Report

Devices descending from K993553

2 later devices reach Gti-Fviii Inhibitor Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082205Factor Viii Antibody ScreenGenetic Testing Institute20081—
+2K183440CRYOcheck FVIII Inhibitor KitPrecision Biologic, Inc.20190—