FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS— 510(k) K102607

Name: FDA 510(k) clearance K102607
Creator: U.S. Food and Drug Administration
Published: 2010-12-03

Substantially Equivalent

Biomedical Diagnostics (Bmd) SA

FDA 510(k) clearance K102607 for FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS, Substantially Equivalent on 2010-12-03. Applicant: Biomedical Diagnostics (Bmd) SA. Device class: 2.

Clearance details

Applicant: Biomedical Diagnostics (Bmd) SA
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2010-09-10
Decision date: 2010-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marne La Vallee Cedex 2, FR

Download summary PDF View on FDA.gov ↗

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