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FDA 510(k)

T2Bacteria® Panel

K-Number: K233184 · 2024-02-08

ApplicantT2biosystems, Inc.
Decision Date2024-02-08
Product CodeQBX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

T2Bacteria® Panel is a medical device manufactured by T2biosystems, Inc.. It received FDA 510(k) clearance on 2024-02-08 under approval number K233184. The device is classified under product code QBX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T2Bacteria® Panel?

T2Bacteria® Panel is a medical device that received FDA 510(k) clearance on 2024-02-08. It is manufactured by T2biosystems, Inc.. The 510(k) number is K233184.

When was T2Bacteria® Panel approved by the FDA?

T2Bacteria® Panel received FDA 510(k) clearance on 2024-02-08, under approval number K233184.

What company makes T2Bacteria® Panel?

T2Bacteria® Panel is manufactured by T2biosystems, Inc..

What is the FDA product code for T2Bacteria® Panel?

The FDA product code for T2Bacteria® Panel is QBX.

Other Devices by T2biosystems, Inc.

K173536T2Candida 1.1 Panel K172708T2Bacteria Panel K231336T2 Biothreat Panel K234063T2Candida 1.1 Panel

Related Devices (Code: QBX)

K172708T2Bacteria PanelT2biosystems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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