T2Bacteria® Panel— 510(k) K233184

Substantially Equivalent

T2biosystems, Inc.

FDA 510(k) clearance K233184 for T2Bacteria® Panel, Substantially Equivalent on 2024-02-08. Applicant: T2biosystems, Inc..

Clearance details

Applicant: T2biosystems, Inc.
Product code: Code QBX
Advisory panel: Microbiology
Date received: 2023-09-28
Decision date: 2024-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

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