General Atomics - FDA 510(k) Cleared Devices

General Atomics, is a diversified technology company with a manufacturing facility in San Diego, US. Founded in 1955, the company specializes in high-technology solutions across nuclear energy, electromagnetic systems, and advanced electronics. GA operates one of the largest fusion programs in industry and manufactures TRIGA® research reactors used worldwide.

The company has received 6 FDA 510(k) clearances from 6 total submissions, all in Chemistry devices. Clearances span from 2003 to 2009. This regulatory record reflects GA's historical involvement in clinical laboratory assay development, including enzymatic assays for lipid panels, hemoglobin variants, and metabolic markers.

GA's cleared Chemistry devices include diagnostic assays for lipoprotein analysis, apolipoprotein measurement, cholesterol quantification, and specialized metabolic testing. The company is not currently active in FDA 510(k) submissions and should be treated as a historical regulatory record.

Explore the complete list of device names, product codes, and clearance dates in the database.