Medical Device Manufacturer · FR , Marne La Vallee Cedex 2

Biomedical Diagnostics (Bmd) SA - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2005

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biomedical Diagnostics (Bmd) SA Immunology ✕

10 devices

1-10 of 10

Cleared Dec 03, 2010

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS

Immunology · 84d

Cleared Nov 03, 2010

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

Immunology · 215d

Cleared Dec 21, 2007

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007

Immunology · 308d

Cleared Dec 19, 2007

MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006

Immunology · 232d

Cleared Nov 21, 2006

FIDIS TM THYRO, MODEL MX002

Immunology · 148d

Cleared May 02, 2006

Immunology · 77d

Cleared Mar 29, 2006

Immunology · 114d

Cleared Mar 13, 2006

FIDIS CONNECTIVE 10, MODEL MX006

Immunology · 73d

Cleared Mar 02, 2006

FIDIS VASCULITIS, MODEL MX007

Immunology · 127d

Cleared Oct 03, 2005

FIDIS CONNECTIVE 8

Immunology · 238d