Euro-Diagnostica AB is one of 59 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
Euro-Diagnostica AB - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Euro-Diagnostica AB has 6 FDA 510(k) cleared medical devices. Based in Malmo, SE.
Historical record: 6 cleared submissions from 1997 to 2010. Primary specialty: Immunology.
Browse the FDA 510(k) cleared devices submitted by Euro-Diagnostica AB Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Euro-Diagnostica AB
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