Medical Device Manufacturer · US , Irving , TX

Olympus Life Science Research Europa GmbH (Europa)

3 submissions · 3 cleared · Since 2008
3
Total
3
Cleared
0
Denied

Olympus Life Science Research Europa GmbH (Europa) — FDA 510(k) Submissions

Olympus Life Science Research Europa GmbH (Europa) has submitted 3 FDA 510(k) premarket notifications since 2008, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Human Chorionic Gonadotropin, Diazo Colorimetry, Bilirubin, Kit, Test,alpha-fetoprotein For Testicular Cancer . Use the specialty filter in the sidebar to narrow results.

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All3 Chemistry 2 Immunology 1