510(k) Report

Devices descending from K152614

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191288Acuitas AMR Gene PanelOpgen, Inc.20210—
+1K190275GenePOC CarbaGenepoc, Inc.20190—
+1K160901Xpert Carba-RCepheid20163—
+2K190613BD MAX Check-Points CPOCheck-Points Health B.V.20190—
+2K173263Xpert Carba-RCepheid20181—
+3K261867Xpert Carba-RCepheid®20260—