Medical Device Manufacturer · US , Irving , TX

Olympus Life & Material Science Europa GmbH (Irish - FDA 510(k) Clear...

3 submissions · 3 cleared · Since 2007

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Olympus Life & Material Science Europa GmbH (Irish Chemistry ✕

2 devices

1-2 of 2

Cleared Aug 21, 2007

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102,...

Chemistry · 160d

Cleared Jun 04, 2007

OLYMPUS CK-MB REAGENT

Chemistry · 69d