BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SYNTHETIC BROTH A.O.A.C.

    K Number: K841661 · Decision May 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    93
    Review Days
    18

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    Basic Information

    Device Name
    SYNTHETIC BROTH A.O.A.C.
    K Number
    K841661
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Oxoid U.S.A., Inc.
    Date Received
    April 23, 1984
    Decision Date
    May 11, 1984
    Product Code
    JST
    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
    JST Kit, Fastidious Organisms

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