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

    LEGIONELLA DIFFERENTIATION DISK

    K Number: K834067 · Decision Jan 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    137
    Review Days
    39

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    Basic Information

    Device Name
    LEGIONELLA DIFFERENTIATION DISK
    K Number
    K834067
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Remel Co.
    Date Received
    November 25, 1983
    Decision Date
    January 3, 1984
    Product Code
    GRO
    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
    GRO Antisera, Fluorescent, All Types, Hemophilus Spp.

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