510(k) Report

Devices descending from K091109

5 later devices reach Xpert C. Difficile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110203Xpert C. Difficle/Epi AssayCepheid20111—
+1K100818Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit…Meridian Bioscience, Inc.20102—
+2K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc.201204
+2K110012Illumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc.201112
+3K113433Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc.20120—