510(k) Report

Devices descending from K972359

19 later devices reach Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122187Vreselect Culture MediumBio-Rad20123—
+1K103684Vreselect Culture MediumBio-Rad20110—
+1K102416BD Geneohm Vanr AssayBd Diagnostics Science20111—
+1K091025Chromid Vre Agar, Model: Ref 43 851bioMerieux, Inc.201011
+1K092953Xpert VanA AssayCepheid20098—
+1K061686Idi-Vanr AssayGeneohm Sciences Canada, Inc.20069—
+2K243405Xpert vanACepheid®20240—
+2K190553HardyCHROM CREHardy Diagnostics201901
+2K181092CHROMID CARBA agar (CARB)Biomerieux S.A.201801
+2K160512HardyCHROM ESBLHardy Diagnostics20161—
+2K152614Xpert Carba-RCepheid20166—
+2K123753Imdx Vanr for Abbott M2000Intelligent Medical Devices, Inc.20130—
+3K191288Acuitas AMR Gene PanelOpgen, Inc.20210—
+3K190275GenePOC CarbaGenepoc, Inc.20190—
+3K162620Remel Spectra ESBLRemel, Inc.20170—
+3K160901Xpert Carba-RCepheid20163—
+4K190613BD MAX Check-Points CPOCheck-Points Health B.V.20190—
+4K173263Xpert Carba-RCepheid20181—
+5K261867Xpert Carba-RCepheid®20260—