T2 Biothreat Panel— 510(k) K231336

Substantially Equivalent

T2biosystems, Inc.

FDA 510(k) clearance K231336 for T2 Biothreat Panel, Substantially Equivalent on 2023-09-15. Applicant: T2biosystems, Inc..

Clearance details

Applicant: T2biosystems, Inc.
Product code: Code QVR
Advisory panel: Immunology
Date received: 2023-05-08
Decision date: 2023-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

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