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
K163336 11/28/2016 xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR Luminex Molecular Diagnostics, Inc.


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