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

    LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST

    K Number: K864006 · Decision Apr 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    57
    Review Days
    187

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    Basic Information

    Device Name
    LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
    K Number
    K864006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Diagnostic Technologies, Inc.
    Date Received
    October 15, 1986
    Decision Date
    April 20, 1987
    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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