Cleared Traditional

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007

K070458 · Biomedical Diagnostics (Bmd) SA · Immunology
Dec 2007
Decision
308d
Days
Class 2
Risk

About This 510(k) Submission

K070458 is an FDA 510(k) clearance for the MODIFICATION TO FIDIS VASCULITIS, MODEL MX007, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on December 21, 2007, 308 days after receiving the submission on February 16, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K070458 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2007
Decision Date December 21, 2007
Days to Decision 308 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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