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Luminex Corporation

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories12
Latest FDA decision2026-05-19
TypeNumberDevice NameCodeDateActions
510(k) K253722 LIAISON PLEX Gastrointestinal Flex AssayPCH2026-05-19 View
510(k) K243490 LIAISON PLEX Gram-Positive Blood Culture AssayPAM2025-06-06 View
510(k) K243013 LIAISON PLEX Gram-Negative Blood Culture AssayPEN2025-04-18 View
510(k) K240627 LIAISON PLEX Yeast Blood Culture AssayPEO2024-06-04 View
510(k) K233410 LIAISON PLEX Respiratory Flex AssayQOF2024-03-01 View
510(k) K191742 ARIES MRSA AssayNQX2019-09-25 View
510(k) K172402 ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX2017-10-30 View
510(k) K171441 ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension KitOZN2017-07-21 View
510(k) K163626 ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitOZZ2017-05-02 View
510(k) K162772 ARIES GBS AssayNJR2016-12-23 View
510(k) K161220 ARIES® Flu A/B & RSV AssayOCC2016-08-02 View
510(k) K161495 ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)OOI2016-06-30 View
510(k) K160517 ARIES SystemOOI2016-04-12 View
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