Luminex Corporation is one of 21983 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Luminex Corporation - FDA 510(k) Cleared Devices
Recent clearances: LIAISON PLEX Gastrointestinal Flex Assay, LIAISON PLEX Gram-Positive Blood Culture Assay, LIAISON PLEX Gram-Negative Blood Culture Assay
15
Total
15
Cleared
0
Denied
Luminex Corporation has 15 FDA 510(k) cleared microbiology devices. Based in Austin, US.
Latest FDA clearance: May 2026. Active since 2015.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
5 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Luminex Corporation
15 devices
Cleared
May 19, 2026
LIAISON PLEX Gastrointestinal Flex Assay
Microbiology
176d
Cleared
Jun 06, 2025
LIAISON PLEX Gram-Positive Blood Culture Assay
Microbiology
206d
Cleared
Apr 18, 2025
LIAISON PLEX Gram-Negative Blood Culture Assay
Microbiology
203d
Cleared
Jun 04, 2024
LIAISON PLEX Yeast Blood Culture Assay
Microbiology
90d
Cleared
Mar 01, 2024
LIAISON PLEX Respiratory Flex Assay
Microbiology
147d
Cleared
Sep 25, 2019
ARIES MRSA Assay
Microbiology
86d
Cleared
CT
Oct 30, 2017
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
Microbiology
82d
Cleared
CT
Jul 21, 2017
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File...
Microbiology
66d
Cleared
CT
May 02, 2017
ARIES Bordetella Assay
Microbiology
131d
Cleared
Dec 23, 2016
ARIES GBS Assay
Microbiology
81d
Cleared
CT
Aug 02, 2016
ARIES® Flu A/B & RSV Assay
Microbiology
95d
Cleared
Jun 30, 2016
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV...
Microbiology
29d