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

    DIRECT FA CONJUGATE FOR LEGIONELLA SP

    K Number: K813339 · Decision Dec 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    24

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    Basic Information

    Device Name
    DIRECT FA CONJUGATE FOR LEGIONELLA SP
    K Number
    K813339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Springwood Microbiologicals
    Date Received
    November 24, 1981
    Decision Date
    December 18, 1981
    Product Code
    LHL
    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
    LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

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