510(k) Report

Devices descending from K182692

3 later devices reach BD MAX CTGCTV2, BD MAX System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210585BD CTGCTV2Becton, Dickinson and Company202211
+1K193081Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software)…Rheonix, Inc.20210—
+2K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,20250—