T2Candida 1.1 Panel— 510(k) K234063

Substantially Equivalent

T2biosystems, Inc.

FDA 510(k) clearance K234063 for T2Candida 1.1 Panel, Substantially Equivalent on 2024-09-13. Applicant: T2biosystems, Inc..

Clearance details

Applicant: T2biosystems, Inc.
Product code: Code PII
Advisory panel: Microbiology
Date received: 2023-12-22
Decision date: 2024-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

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