BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS

    K Number: K102607 · Decision Dec 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    179
    Applicant Total
    10
    Review Days
    84

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    Basic Information

    Device Name
    FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
    K Number
    K102607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomedical Diagnostics (Bmd) SA
    Date Received
    September 10, 2010
    Decision Date
    December 3, 2010
    Product Code
    LLL
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLL Extractable Antinuclear Antibody, Antigen And Control

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    K053653 FIDIS CONNECTIVE 10, MODEL MX006
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