510(k) Report

Devices descending from K212427

2 later devices reach cobas Cdiff nucleic acid test for use on the cobas Liat System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…Roche Molecular Systems, Inc.20260—
+1K243730Xpert C. difficile/EpiCepheid®20250—