510(k) Report

Devices descending from K872845

3 later devices reach Bion Antinuclear Antibody (Ana)Test Kit/Contr Serum through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042680Rhigene Hep-Ana Test SystemCorgenix, Inc.20040—
+1K013213Hyperion Visiquant Ana Test KitHyperion, Inc.20021—
+2K022800Visiquant Anti-Nuclear Antibody Test SystemHyperion, Inc.20020—