Medical Device Manufacturer · US , Chatsworth , CA

Iris International, Inc.

3 submissions · 3 cleared · Since 2005
3
Total
3
Cleared
0
Denied

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.

3 devices
1–3 of 3
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