Device
Atlas
510(k)
Recalls
Companies
Specialties
Home
›
Companies
›
T2biosystems, Inc.
T2biosystems, Inc.
Medical device manufacturer in Lexington, MA.
5
510(k) clearances
0
PMA approvals
0
recalls
Device types
PII Candida Species Nucleic Acid Detection System
2
QBX Direct Blood Bacterial Nucleic Acid…
2
QVR Multiplex Nucleic Acid Detection System For…
1
510(k) clearances
510(k)
Device
Decision
K234063
T2Candida 1.1 Panel
PII · Traditional
09/13/2024
SE
K233184
T2Bacteria® Panel
QBX · Traditional
02/08/2024
SE
K231336
T2 Biothreat Panel
QVR · Traditional
09/15/2023
SE
K172708
T2Bacteria Panel
QBX · Traditional
05/24/2018
SE
K173536
T2Candida 1.1 Panel
PII · Special
12/12/2017
SE