Medical Device Manufacturer · US , Irving , TX

Olympus Life Science Research Europa GmbH (Europa) - FDA 510(k) Clear...

3 submissions · 3 cleared · Since 2008

Recent clearances: OLYMPUS AFP - ALPHA-FETOPROTEIN, OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181, OLYMPUS TOTAL BHCG TEST SYSTEN

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Olympus Life Science Research Europa GmbH (Europa) Chemistry ✕

2 devices

1-2 of 2

Cleared Sep 05, 2008

OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181

Chemistry · 199d

Cleared Sep 03, 2008

OLYMPUS TOTAL BHCG TEST SYSTEN

Chemistry · 233d