FDA applicant
Luminex Molecular Diagnostics, Inc.
FDA records 26 decisions for Luminex Molecular Diagnostics, Inc. (Toronto, CA) from 2008 to 2024: 24 510(k) clearances and 2 De Novo grants. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and PCH (Gastrointestinal Pathogen Panel Multiplex…). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 11 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Luminex Molecular Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Luminex Molecular Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Luminex”
FDA records each applicant name separately; these may or may not be the same firm.