T2biosystems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K234063T2Candida 1.1 PanelSeptember 13, 2024
K233184T2Bacteria® PanelFebruary 8, 2024
K231336T2 Biothreat PanelSeptember 15, 2023
K172708T2Bacteria PanelMay 24, 2018
K173536T2Candida 1.1 PanelDecember 12, 2017
DEN140019T2CANDIDA AND T2DX INSTRUMENTSeptember 22, 2014