510(k) K231336

Device: T2 Biothreat Panel
Applicant: T2biosystems, Inc.
510(k) number: K231336
Product code: QVR
Decision: Substantially Equivalent (SESE)
Decision date: 2023-09-15
Date received: 2023-05-08
Regulation: 866.4000
Classification name: Multiplex Nucleic Acid Detection System For Biothreat Agents
Medical specialty: Immunology
Review panel: Immunology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
M70883113970	T2Biothreat® QCheck Negative Kit	T2 BIOSYSTEMS, INC.	2023-11-07
M70883113950	T2Biothreat® QCheck Positive Kit	T2 BIOSYSTEMS, INC.	2023-11-07
M70880113930	T2Biothreat® Reagent Trays	T2 BIOSYSTEMS, INC.	2023-11-07
M70890114000	T2Biothreat® Cartridge Kit	T2 BIOSYSTEMS, INC.	2023-11-07
M70885113983	T2Biothreat® QCheck Negative Kit	T2 BIOSYSTEMS, INC.	2023-11-07
M70885113963	T2Biothreat® QCheck Positive Kit	T2 BIOSYSTEMS, INC.	2023-11-07
M70880113943	T2Biothreat® Reagent Trays	T2 BIOSYSTEMS, INC.	2023-11-07

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K261362	Xpert Hemorrhagic Fever	Cepheid	2026-08-07
K213362	BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel	Biofire Defense, LLC	2023-03-22