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FDA 510(k) Applications Submitted by Jennifer Grimes
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170492
02/17/2017
xTAG CYP2D6 Kit v3
Luminex Molecular Diagnostics, Inc.
K172402
08/09/2017
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
Luminex Corporation
K193167
11/15/2019
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
Luminex Molecular Diagnostics, Inc.
K163336
11/28/2016
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
Luminex Molecular Diagnostics, Inc.
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