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

    NORMAL GOAT SERUM

    K Number: K833318 · Decision Jan 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    27
    Applicant Total
    10
    Review Days
    99

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    Basic Information

    Device Name
    NORMAL GOAT SERUM
    K Number
    K833318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Biosan Laboratories, Inc.
    Date Received
    September 26, 1983
    Decision Date
    January 3, 1984
    Product Code
    DHX
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DHX System, Test, Carcinoembryonic Antigen

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    K833192 NORMAL URINE CONTROL
    K833191 ABNORMAL URINE CONTROL
    K833320 AMBERLITE CG50 RESIN, 100-200 MESH
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