510(k) Report

Devices descending from K160901

3 later devices reach Xpert Carba-R through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190613BD MAX Check-Points CPOCheck-Points Health B.V.20190—
+1K173263Xpert Carba-RCepheid20181—
+2K261867Xpert Carba-RCepheid®20260—