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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact