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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