510(k) Report

Devices descending from K971182

4 later devices reach Tox a/B Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033479Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc.20042—
+1K030404C. Difficile Tox a/B IITechlab, Inc.20032—
+2K082499C. Diff Quik Chek CompleteTechlab, Inc.20090—
+2K050891Tox a/B Quick ChekTechlab, Inc.20051—