Beckman Coulter - FDA 510(k) Cleared Devices

Beckman Coulter, is a global diagnostics company specializing in clinical laboratory instruments and assays. The company operates with a manufacturing facility in Miami, US, and provides comprehensive diagnostic solutions across immunology, hematology, chemistry, and microbiology disciplines.

The company has received 6 FDA 510(k) clearances from 8 total submissions since 2017. Immunology devices, particularly flow cytometers and related panels, represent a dominant category in the company's cleared portfolio. The latest FDA 510(k) clearance was granted in 2024, reflecting continued regulatory activity and product innovation.

Beckman Coulter's cleared devices include advanced flow cytometry systems, hematology analyzers, chemistry assays, and microbiology instruments designed to support clinical decision-making. The company's product portfolio addresses critical diagnostic needs in sepsis detection, cellular analysis, and immunological testing across healthcare settings worldwide.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database to review the company's full regulatory record.