The following data is part of a premarket notification filed by Biomedical Diagnostics (bmd) Sa with the FDA for Fidis Vasculitis Assay Kit And Analyzer And Caris System.
Device ID | K100917 |
510k Number | K100917 |
Device Name: | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM |
Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
Applicant | BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG Marne La Vallee Cedex 2, FR 77435 |
Contact | Courivaud Christelle |
Correspondent | Courivaud Christelle BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG Marne La Vallee Cedex 2, FR 77435 |
Product Code | MOB |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-02 |
Decision Date | 2010-11-03 |
Summary: | summary |