Medical Device Manufacturer · US , Irving , TX

Olympus Life & Material Science Europa GmbH (Irish

3 submissions · 3 cleared · Since 2007
3
Total
3
Cleared
0
Denied

Olympus Life & Material Science Europa GmbH (Irish — FDA 510(k) Submissions

Olympus Life & Material Science Europa GmbH (Irish has submitted 3 FDA 510(k) premarket notifications since 2007, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Fibrin Split Products, Radioimmunoassay, Free Thyroxine, Colorimetric Method, Cpk Or Isoenzymes . Use the specialty filter in the sidebar to narrow results.

3 devices
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All3 Chemistry 2 Hematology 1