Medical Device Manufacturer · SE , Malmo

Euro-Diagnostica AB - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1997

Recent clearances: CCPOINT, IMMUNOSCAN CCPLUS, EDIA ANTI-CCP

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Euro-Diagnostica AB Immunology ✕

6 devices

1-6 of 6

Cleared Dec 01, 2010

Immunology · 344d

Cleared Nov 19, 2009

IMMUNOSCAN CCPLUS

Immunology · 163d

Cleared Dec 04, 2006

Immunology · 138d

Cleared Oct 29, 1997

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT

Immunology · 190d

Cleared Oct 29, 1997

IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT

Immunology · 175d

Cleared Oct 29, 1997

IMMUNOSCAN PR3-ANCA

Immunology · 175d