K-number	DEN140019
Device name	T2CANDIDA AND T2DX INSTRUMENT
Applicant	T2biosystems, Inc.
Product code	PII
Device class	Class II
Decision date	Sep 22, 2014
Decision	Not Substantially Equivalent
Regulation	866.3960

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View the full FDA submission: accessdata.fda.gov

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T2CANDIDA AND T2DX INSTRUMENT

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