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FDA 510(k)

T2 Biothreat Panel

K-Number: K231336 · 2023-09-15

ApplicantT2biosystems, Inc.
Decision Date2023-09-15
Product CodeQVR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

T2 Biothreat Panel is a medical device manufactured by T2biosystems, Inc.. It received FDA 510(k) clearance on 2023-09-15 under approval number K231336. The device is classified under product code QVR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T2 Biothreat Panel?

T2 Biothreat Panel is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by T2biosystems, Inc.. The 510(k) number is K231336.

When was T2 Biothreat Panel approved by the FDA?

T2 Biothreat Panel received FDA 510(k) clearance on 2023-09-15, under approval number K231336.

What company makes T2 Biothreat Panel?

T2 Biothreat Panel is manufactured by T2biosystems, Inc..

What is the FDA product code for T2 Biothreat Panel?

The FDA product code for T2 Biothreat Panel is QVR.

Other Devices by T2biosystems, Inc.

K173536T2Candida 1.1 Panel K172708T2Bacteria Panel K234063T2Candida 1.1 Panel K233184T2Bacteria® Panel

Related Devices (Code: QVR)

K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelBiofire Defense, LLC

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.

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