FDA 510(k)

T2Bacteria® Panel

K-Number: K233184 · 2024-02-08

Decision Date2024-02-08

Product CodeQBX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

T2Bacteria® Panel is the device name listed in this FDA 510(k) record. The listed applicant is T2biosystems, Inc.. It received FDA 510(k) clearance on 2024-02-08 under 510(k) 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. The listed applicant is T2biosystems, Inc.. The 510(k) number is K233184.

When did T2Bacteria® Panel receive FDA 510(k) clearance?

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

Who is the listed applicant for T2Bacteria® Panel?

The FDA 510(k) record lists T2biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T2Bacteria® Panel?

The FDA product code for T2Bacteria® Panel is QBX.

Other records listing T2biosystems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234063T2Candida 1.1 Panel K231336T2 Biothreat Panel K172708T2Bacteria Panel K173536T2Candida 1.1 Panel

Related Devices (Code: QBX)

K172708T2Bacteria PanelT2biosystems, Inc.

Official Source

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