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

    ANTI-HAV

    K Number: K100903 · Decision Oct 5, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    187

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    Basic Information

    Device Name
    ANTI-HAV
    K Number
    K100903
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3310
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Roche Professional Diagnostics
    Date Received
    April 1, 2010
    Decision Date
    October 5, 2010
    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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