510(k) Report

Devices descending from K041003

3 later devices reach Immunocard Toxins a & B, Model 712050 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.20210—
+1K082499C. Diff Quik Chek CompleteTechlab, Inc.20090—
+1K050891Tox a/B Quick ChekTechlab, Inc.20051—