The following data is part of a premarket notification filed by Biomedical Diagnostics (bmd) Sa with the FDA for Modification To Fidis Vasculitis, Model Mx007.
Device ID | K070458 |
510k Number | K070458 |
Device Name: | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-16 |
Decision Date | 2007-12-21 |
Summary: | summary |