Medical Device Manufacturer · FR , Marne La Vallee Cedex 2

Biomedical Diagnostics (Bmd) SA

10 submissions · 10 cleared · Since 2005
10
Total
10
Cleared
0
Denied

Biomedical Diagnostics (Bmd) SA — FDA 510(k) Submissions

Biomedical Diagnostics (Bmd) SA has submitted 10 FDA 510(k) premarket notifications since 2005, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Extractable Antinuclear Antibody, Antigen And Control, Test System, Antineutrophil Cytoplasmic Antibodies (anca), Antibodies, Gliadin, Anti-dna Antibody, Antigen And Control, System, Test, Thyroid Autoantibody . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
K102607 · LLL Extractable Antinuclear... · Immunology
Dec 2010 84d
FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
K100917 · MOB Test System,... · Immunology
Nov 2010 215d
MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
K070458 · MOB Test System,... · Immunology
Dec 2007 308d
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
K071210 · LKO Anti-rnp Antibody,... · Immunology
Dec 2007 232d
FIDIS TM THYRO, MODEL MX002
K061794 · JZO System, Test, Thyroid... · Immunology
Nov 2006 148d
FIDIS DSDNA
K060380 · LSW Anti-dna Antibody,... · Immunology
May 2006 77d
FIDIS CELIAC
K053383 · MST Antibodies, Gliadin · Immunology
Mar 2006 114d
FIDIS CONNECTIVE 10, MODEL MX006
K053653 · LLL Extractable Antinuclear... · Immunology
Mar 2006 73d
FIDIS VASCULITIS, MODEL MX007
K053012 · MOB Test System,... · Immunology
Mar 2006 127d
FIDIS CONNECTIVE 8
K050286 · LLL Extractable Antinuclear... · Immunology
Oct 2005 238d
Filters
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