# Illumina, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 6 (2010–2024): 4 510(k) clearances and 2 original PMA approvals
- Product codes: PQP (2), NPQ (1), NSU (1), PFR (1), PFS (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Autogenomics, Incorporated: 2 (https://510kreport.com/company/autogenomics)
- Luminex Molecular Diagnostics, Inc.: 2 (https://510kreport.com/company/luminex-molecular-diagnostics)

## Recent decisions
- P230011: TruSight Oncology Comprehensive (Aug 21, 2024)
- P160038: Praxis Extended RAS Panel (Jun 29, 2017)
- K124006: Illumina Miseqdx  Cystic Fibrosis 139-Variant Assay (Nov 19, 2013)
- K132750: Illumina Miseqdx Cystic Fibrosis Clinical Sequencing Assay (Nov 19, 2013)
- K093129: Illumina Verncode Genotyping Test for Facor V and Factor II (Apr 28, 2010)
- K093128: Illumina Beadxpress System (Apr 28, 2010)

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