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FDA 510(k)

T2Bacteria Panel

K-Number: K172708 · 2018-05-24

ApplicantT2biosystems, Inc.
Decision Date2018-05-24
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 2018-05-24 under approval 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. It is manufactured by T2biosystems, Inc.. The 510(k) number is K172708.

When was T2Bacteria Panel approved by the FDA?

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

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 K231336T2 Biothreat Panel K234063T2Candida 1.1 Panel K233184T2Bacteria® Panel

Related Devices (Code: QBX)

K233184T2Bacteria® 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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