Medical Device Manufacturer · FI , 02101 Espoo

Orion Diagnostica, Div. Orion Corp. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1995

Recent clearances: PYLORISET EIA-G (68926)

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orion Diagnostica, Div. Orion Corp. Immunology ✕

2 devices

1-2 of 2

Cleared Oct 10, 2003

ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL

Immunology · 141d

Cleared Dec 03, 2002

ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA...

Immunology · 153d