510(k) Report

Devices descending from K151589

6 later devices reach BD Max CT/GC/TV, BD Max Instrument through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202977Alinity m STI AssayAbbott Molecular, Inc.20221—
+1K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company20193—
+2K222379Alinity m STI AssayAbbott Molecular, Inc.202301
+2K210585BD CTGCTV2Becton, Dickinson and Company202211
+2K193081Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software)…Rheonix, Inc.20210—
+3K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,20250—