FDA 510(k) Applications Submitted by LUMINEX CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K161495 06/01/2016 ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) LUMINEX CORPORATION
K162772 10/03/2016 ARIES GBS Assay LUMINEX CORPORATION
K172402 08/09/2017 ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit Luminex Corporation
K191742 07/01/2019 ARIES MRSA Assay Luminex Corporation
K163626 12/22/2016 ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit Luminex Corporation
K151906 07/13/2015 ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) LUMINEX CORPORATION
K151917 07/13/2015 ARIES System LUMINEX CORPORATION
K160517 02/24/2016 ARIES System LUMINEX CORPORATION
K161220 04/29/2016 ARIES« Flu A/B & RSV Assay LUMINEX CORPORATION
K171441 05/16/2017 ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit Luminex Corporation


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