Sysmex America, Inc.

Sysmex America, Inc. — FDA 510(k) Submissions

Sysmex America, Inc. has submitted 30 FDA 510(k) premarket notifications since 2003, of which 30 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Differential Cell, Counter, Urine Particle, System, Multipurpose For In Vitro Coagulation Studies, Counter, Cell, Automated (particle Counter), Radioimmunoassay, Thyroid-stimulating Hormone . Use the specialty filter in the sidebar to narrow results.