510(k) Report

Devices descending from K100818

2 later devices reach Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110012Illumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc.201112
+2K113433Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc.20120—