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FDA 510(k) Applications for Medical Device Product Code "PII"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN140019
T2 BIOSYSTEMS, INC
T2CANDIDA AND T2DX INSTRUMENT
09/22/2014
K173536
T2 Biosystems, Inc.
T2Candida 1.1 Panel
12/12/2017
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