# Luminex Corporation

- Location (FDA's records): Austin, TX
- FDA decisions: 18 (2008–2026): 18 510(k) clearances
- Names in FDA's records: Luminex Corporation (15); Luminex Corp. (3)
- Product codes: NSU (3), OOI (3), PGI (1), OZZ (1), OCC (1), PAM (1), NQX (1), QOF (1), PGX (1), NJR (1), PEN (1), OZN (1)
- 510(k) review time since 2016: median 121 days, against 120 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Meridian Bioscience, Inc.: 2 (https://510kreport.com/company/meridian-bioscience)
- Nanosphere, Inc.: 2 (https://510kreport.com/company/nanosphere)
- Biofire Diagnostics, LLC: 2 (https://510kreport.com/company/biofire-diagnostics)
- Focus Diagnostics, Inc.: 1 (https://510kreport.com/company/focus-diagnostics)
- Geneohm Sciences Canada, Inc.: 1 (https://510kreport.com/company/geneohm-sciences-canada)
- Iquum, Inc.: 1 (https://510kreport.com/company/iquum)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)
- Genmark Diagnostics, Incorporated: 1 (https://510kreport.com/company/genmark-diagnostics)

## Firms that cite its devices most
- Liposcience: 1 (https://510kreport.com/company/liposcience)
- Diasorin Molecular, LLC: 1 (https://510kreport.com/company/diasorin-molecular)
- Elitechgroup: 1 (https://510kreport.com/company/elitechgroup)

## Its most-cited devices
- K151906: 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) (2015), cited by 1
- K163626: ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (2017), cited by 1
- K073506: Luminex LX 100/200 Instrument (2008), cited by 1

## Recent decisions
- K253722: LIAISON PLEX Gastrointestinal Flex Assay (May 19, 2026)
- K243490: LIAISON PLEX Gram-Positive Blood Culture Assay (Jun 6, 2025)
- K243013: LIAISON PLEX Gram-Negative Blood Culture Assay (Apr 18, 2025)
- K240627: LIAISON PLEX Yeast Blood Culture Assay (Jun 4, 2024)
- K233410: LIAISON PLEX Respiratory Flex Assay (Mar 1, 2024)
- K191742: ARIES MRSA Assay (Sep 25, 2019)
- K172402: ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit (Oct 30, 2017)
- K171441: ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit (Jul 21, 2017)

Source page: https://510kreport.com/company/luminex