Medical Device Manufacturer · US , Minneapolis , MN

Orgentec Diagnostika GmbH - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2003

Recent clearances: ORGENTEC RHEUMATOID FACTOR EIA, ANTI-MUTATED CITRULLINATED VIMENTIN EIA, ANA DETECT

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orgentec Diagnostika GmbH Immunology ✕

3 devices

1-3 of 3

Cleared Oct 27, 2010

ORGENTEC RHEUMATOID FACTOR EIA

Immunology · 247d

Cleared Jul 01, 2010

ANTI-MUTATED CITRULLINATED VIMENTIN EIA

Immunology · 329d

Cleared May 02, 2003

Immunology · 39d