510(k) Report

Devices descending from DEN140019

4 later devices reach T2CANDIDA and T2DX Instrument through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172708T2Bacteria PanelT2biosystems, Inc.20181—
+1K173536T2Candida 1.1 PanelT2biosystems, Inc.20171—
+2K234063T2Candida 1.1 PanelT2biosystems, Inc.20240—
+2K233184T2Bacteria® PanelT2biosystems, Inc.20240—