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FDA 510(k) Applications Submitted by Sarah Kalil
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200533
03/02/2020
binx io CT/NG Assay and binx io CT/NG System
binx health Inc
K191352
05/20/2019
binx health io CT/NG Assay
binx health, Inc.
DEN140019
05/27/2014
T2CANDIDA AND T2DX INSTRUMENT
T2 BIOSYSTEMS, INC
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