FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM— 510(k) K100917

Substantially Equivalent

Biomedical Diagnostics (Bmd) SA

FDA 510(k) clearance K100917 for FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM, Substantially Equivalent on 2010-11-03. Applicant: Biomedical Diagnostics (Bmd) SA.

Clearance details

Applicant: Biomedical Diagnostics (Bmd) SA
Product code: Code MOB
Advisory panel: Immunology
Date received: 2010-04-02
Decision date: 2010-11-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Marne La Vallee Cedex 2, FR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.