FIDIS TM THYRO, MODEL MX002— 510(k) K061794

Name: FDA 510(k) clearance K061794
Creator: U.S. Food and Drug Administration
Published: 2006-11-21

Substantially Equivalent

Biomedical Diagnostics (Bmd) SA

FDA 510(k) clearance K061794 for FIDIS TM THYRO, MODEL MX002, Substantially Equivalent on 2006-11-21. Applicant: Biomedical Diagnostics (Bmd) SA. Device class: 2.

Clearance details

Applicant: Biomedical Diagnostics (Bmd) SA
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 2006-06-26
Decision date: 2006-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marne La Vallee Cedex 2, FR

Download summary PDF View on FDA.gov ↗

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