Euro-Diagnostica AB - FDA 510(k) Cleared Devices
Recent clearances: IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT, IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT, IMMUNOSCAN PR3-ANCA
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Euro-Diagnostica AB Immunology ✕
6 devices
Cleared
Dec 01, 2010
CCPOINT
Immunology
344d
Cleared
Nov 19, 2009
IMMUNOSCAN CCPLUS
Immunology
163d
Cleared
Dec 04, 2006
EDIA ANTI-CCP
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