Medical Device Manufacturer · FI , Espoo

Orion Diagnostica, OY - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2004

Recent clearances: QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument, ORION DIAGNOSTICA UNIQ PINP RIA, QUIKREAD CRP CALIBRATOR SET

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orion Diagnostica, OY Chemistry ✕

3 devices

1-3 of 3

Cleared May 04, 2005

ORION DIAGNOSTICA UNIQ PINP RIA

Chemistry · 173d

Cleared Nov 18, 2004

QUIKREAD CRP CALIBRATOR SET

Chemistry · 52d

Cleared Sep 24, 2004

QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085

Chemistry · 15d