510(k) Report

Devices descending from K041951

3 later devices reach Xpect Clostridium Difficile Toxin a/B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102242Osom C. Difficile Toxin a/B TestGenzyme Corporation201001
+1K082499C. Diff Quik Chek CompleteTechlab, Inc.20090—
+1K050891Tox a/B Quick ChekTechlab, Inc.20051—