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

    VIDAS LYME IGM

    K Number: K122979 · Decision Jun 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    109
    Applicant Total
    7
    Review Days
    251

    Basic Information

    Device Name
    VIDAS LYME IGM
    K Number
    K122979
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIOMERIEUX SA
    Date Received
    September 26, 2012
    Decision Date
    June 4, 2013
    Product Code
    LSR
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LSR Reagent, Borrelia Serological Reagent

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    Other Clearances by BIOMERIEUX SA

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