Medical Device Manufacturer · DE , Freiburg

Sweden Diagnostics (Germany) GmbH - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2004

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sweden Diagnostics (Germany) GmbH Immunology ✕

8 devices

1-8 of 8

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