Osang, LLC - FDA 510(k) Cleared Devices

Osang, LLC develops diagnostic testing solutions for healthcare providers, laboratories, and communities worldwide. Established in 1996 and headquartered in Seoul, Korea, the company operates a manufacturing facility in Pasadena, California. Osang specializes in rapid diagnostic kits and molecular systems across multiple therapeutic areas.

The company has received 2 FDA 510(k) clearances from 2 total submissions, with all submissions focused on Microbiology devices. Both clearances were granted in 2025, reflecting active regulatory engagement. Osang's cleared devices include antigen self-tests for COVID-19 and combined COVID-19/Flu detection, demonstrating expertise in rapid immunodiagnostic platforms.

Osang has delivered over 100 million COVID-19 tests globally and operates in more than 110 countries. The company holds 189 patents worldwide and maintains certifications including FDA authorizations, ISO 13485, and MDSAP. Its product portfolio spans molecular diagnostics, immunological assays, and biological monitoring systems.

Explore the company's cleared device names, product codes, and clearance dates in the database above.

Regulatory submissions have been managed by Hyman, Phelps & McNamara, P.C. and Hyman, Phelps, and McNamara, P.C..