T2Bacteria® Panel— 510(k) K233184

Substantially Equivalent

T2biosystems, Inc.

FDA 510(k) clearance K233184 for T2Bacteria® Panel, Substantially Equivalent on 2024-02-08. Applicant: T2biosystems, Inc.. Device class: 2.

Clearance details

Applicant: T2biosystems, Inc.
Product code: Code QBX
Device class: Class 2
Regulation: 21 CFR 866.3960
Advisory panel: Microbiology
Date received: 2023-09-28
Decision date: 2024-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QBX

K172708 — T2Bacteria Panel2018-05-24

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K173536 — T2Candida 1.1 Panel2017-12-12
DEN140019 — T2CANDIDA AND T2DX INSTRUMENT2014-09-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.