T2Bacteria Panel— 510(k) K172708

Substantially Equivalent

T2biosystems, Inc.

FDA 510(k) clearance K172708 for T2Bacteria Panel, Substantially Equivalent on 2018-05-24. Applicant: T2biosystems, Inc.. Device class: 2.

Clearance details

Applicant: T2biosystems, Inc.
Product code: Code QBX
Device class: Class 2
Regulation: 21 CFR 866.3960
Advisory panel: Microbiology
Date received: 2017-09-08
Decision date: 2018-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.