BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MONOLISA ANTI-HAV IGM EIA

    K Number: K092353 · Decision Oct 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    82
    Review Days
    86

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    Basic Information

    Device Name
    MONOLISA ANTI-HAV IGM EIA
    K Number
    K092353
    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, Inc.
    Date Received
    August 4, 2009
    Decision Date
    October 29, 2009
    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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