Medical Device Manufacturer · AU , Pyrmont

Gradipore , Ltd.

4 submissions · 4 cleared · Since 1990
4
Total
4
Cleared
0
Denied

Gradipore , Ltd. — FDA 510(k) Submissions

Gradipore , Ltd. has submitted 4 FDA 510(k) premarket notifications since 1990, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagent, Russel Viper Venom, Test, Time, Partial Thromboplastin, Control, Plasma, Abnormal . Use the specialty filter in the sidebar to narrow results.

4 devices
1–4 of 4
Filters
Filter by Specialty
All4 Hematology 4