FDA 510(k)

T2Bacteria Panel

K-Number: K172708 · 2018-05-24

Decision Date2018-05-24

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 2018-05-24 under 510(k) number K172708. 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 2018-05-24. The listed applicant is T2biosystems, Inc.. The 510(k) number is K172708.

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

T2Bacteria Panel received FDA 510(k) clearance on 2018-05-24, under 510(k) number K172708.

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 K233184T2Bacteria® Panel K231336T2 Biothreat Panel K173536T2Candida 1.1 Panel

Related Devices (Code: QBX)

K233184T2Bacteria® 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.