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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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