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

    MONOLISA ANTI-HAV EIA

    K Number: K063318 · Decision May 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    46
    Review Days
    182

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    Basic Information

    Device Name
    MONOLISA ANTI-HAV EIA
    K Number
    K063318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3310
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories
    Date Received
    November 2, 2006
    Decision Date
    May 3, 2007
    Product Code
    LOL
    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
    LOL Hepatitis A Test (Antibody And Igm Antibody)

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