K-number	K234063
Device name	T2Candida 1.1 Panel
Applicant	T2biosystems, Inc.
Product code	PII
Device class	Class II
Decision date	Sep 13, 2024
Decision	Substantially Equivalent
Regulation	866.3960

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View the full FDA submission: accessdata.fda.gov

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T2Candida 1.1 Panel

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