Iris International, Inc.

Iris International, Inc. — FDA 510(k) Submissions

Iris International, Inc. has submitted 3 FDA 510(k) premarket notifications since 2005, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Cell, Automated (particle Counter), Method, Enzymatic, Glucose (urinary, Non-quantitative), Counter, Urine Particle . Use the specialty filter in the sidebar to narrow results.