T2Candida 1.1 Panel— 510(k) K173536

Substantially Equivalent

T2biosystems, Inc.

FDA 510(k) clearance K173536 for T2Candida 1.1 Panel, Substantially Equivalent on 2017-12-12. Applicant: T2biosystems, Inc..

Clearance details

Applicant: T2biosystems, Inc.
Product code: Code PII
Advisory panel: Microbiology
Date received: 2017-11-15
Decision date: 2017-12-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Lexington, MA, US

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