Illumina, Inc. - FDA 510(k) Cleared Devices

Illumina, Inc. is a genomics company specializing in sequencing and array solutions for genetic discovery and analysis. The company operates with a manufacturing facility in San Diego, US.

Illumina received 4 FDA 510(k) clearances from 6 total submissions between 2010 and 2013. The company's cleared devices span pathology and hematology categories, including clinical sequencing assays and genotyping tests. The company has been inactive in FDA submissions for more than a decade and should be treated as a historical regulatory record.

Illumina's FDA-cleared portfolio included next-generation sequencing platforms, cystic fibrosis clinical assays, factor genotyping tests, and microarray systems. These devices supported molecular diagnostics and genetic testing applications across clinical and research settings.

For detailed information on specific device names, product codes, and clearance dates, explore the full 510(k) submission history.