510(k) Report

Devices descending from K061686

9 later devices reach Idi-Vanr Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092953Xpert VanA AssayCepheid20098—
+2K243405Xpert vanACepheid®20240—
+2K152614Xpert Carba-RCepheid20166—
+3K191288Acuitas AMR Gene PanelOpgen, Inc.20210—
+3K190275GenePOC CarbaGenepoc, Inc.20190—
+3K160901Xpert Carba-RCepheid20163—
+4K190613BD MAX Check-Points CPOCheck-Points Health B.V.20190—
+4K173263Xpert Carba-RCepheid20181—
+5K261867Xpert Carba-RCepheid®20260—