510(k) Report

Devices descending from DEN120013

7 later devices reach C. Difficile Nucleic Acid Amplification Test Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170491Solana C. difficile AssayQuidel Corporation20170—
+1K123998Quidel Molecular Direct C. Difficile AssayQuidel Corp.20132—
+1K123355Amplivue C. Difficile AssayQuidel Corporation20121—
+1K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc.201204
+2K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…Luminex Corporation201701
+2K133936Artus C. Difficile QS-RGQ MDX KitQIAGEN GmbH20140—
+2K132235Imdx C.Difficile for Abbott M2000Intelligent Medical Devices, Inc.20130—