Company · US

T2biosystems, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2024. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
PII	Candida Species Nucleic Acid Detection System	3
QBX	Direct Blood Bacterial Nucleic Acid Detection System	2
QVR	Multiplex Nucleic Acid Detection System For Biothreat Agents	1

Decided	510(k)	Device and applicant	Code
Sep 13, 2024	K234063	T2Candida 1.1 Panel T2biosystems, Inc.	PII
Feb 8, 2024	K233184	T2Bacteria® Panel T2biosystems, Inc.	QBX
Sep 15, 2023	K231336	T2 Biothreat Panel T2biosystems, Inc.	QVR
May 24, 2018	K172708	T2Bacteria Panel T2biosystems, Inc.	QBX
Dec 12, 2017	K173536	T2Candida 1.1 Panel T2biosystems, Inc.	PII
Sep 22, 2014	DEN140019	T2CANDIDA AND T2DX INSTRUMENT T2biosystems, Inc.	PII

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.