Sweden Diagnostics (Germany) GmbH is one of 507 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Sweden Diagnostics (Germany) GmbH - FDA 510(k) Cleared Devices
Recent clearances: VARELISA RECOMBI CTD SCREEN, MODEL 13096, VARELISA RECOMBI ANA PROFILE, MODEL 18496, VARELISA SM ANTIBODIES, MODEL 18296
8
Total
8
Cleared
0
Denied
Sweden Diagnostics (Germany) GmbH has 8 FDA 510(k) cleared medical devices. Based in Freiburg, DE.
Historical record: 8 cleared submissions from 2004 to 2005. Primary specialty: Immunology.
Browse the FDA 510(k) cleared devices submitted by Sweden Diagnostics (Germany) GmbH Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Sweden Diagnostics (Germany) GmbH
8 devices
Cleared
Jun 28, 2005
VARELISA RECOMBI CTD SCREEN, MODEL 13096
Immunology
71d
Cleared
Apr 26, 2005
VARELISA RECOMBI ANA PROFILE, MODEL 18496
Immunology
46d
Cleared
Dec 08, 2004
VARELISA SM ANTIBODIES, MODEL 18296
Immunology
72d
Cleared
Aug 02, 2004
CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
Immunology
89d
Cleared
Aug 02, 2004
VARELISA GLIADIN IGG ANTIBODIES
Immunology
74d
Cleared
Jul 19, 2004
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
Immunology
75d
Cleared
Jul 16, 2004
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
Immunology
57d
Cleared
Jun 16, 2004
VARELISA MPO ANCA, MODEL 17648/17696
Immunology
55d