Beckman Coulter

Beckman Coulter — FDA 510(k) Submissions

Beckman Coulter has submitted 8 FDA 510(k) premarket notifications since 2017, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Differential Cell, Flow Cytometric Test System For Hematopoietic Neoplasms, Flow Cytometric Reagents And Accessories., Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment, Electrophoretic Separation, Alkaline Phosphatase Isoenzymes . Use the specialty filter in the sidebar to narrow results.