Healgen Scientific, LLC - FDA 510(k) Cleared Devices

Healgen Scientific, LLC is a leading in-vitro diagnostics (IVD) developer and manufacturer based in Houston, Texas. Established in 2007, the company specializes in high-quality diagnostic testing technologies across multiple therapeutic areas.

Healgen has achieved 27 FDA 510(k) clearances from 27 total submissions since 2012, with no denied submissions on record. The company's regulatory portfolio is dominated by toxicology devices, including drug screening and fentanyl detection products, alongside offerings in chemistry, microbiology, and infectious disease diagnostics. The latest clearance in 2026 demonstrates active ongoing development and commitment to regulatory compliance.

Recent cleared devices include oral fluid drug tests, urine drug screening products, rapid antigen tests for COVID-19 and influenza, and specialized toxicology assays. The company's product range reflects a focus on point-of-care and laboratory-based diagnostic solutions serving clinical, occupational health, and public health markets.

Explore the complete regulatory record, including specific device names, product codes, and clearance dates in the FDA 510(k) database.

Regulatory submissions have been managed by LSI International, Inc., Axteria Biomed Consulting and Healgen Scientific,, LLC.