510(k) Report

Devices descending from K123998

2 later devices reach Quidel Molecular Direct C. Difficile Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…Luminex Corporation201701
+1K133936Artus C. Difficile QS-RGQ MDX KitQIAGEN GmbH20140—