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

    GOAT ANTI-HUMAN C-REACTIVE PROTEIN

    K Number: K791560 · Decision Sep 24, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    125
    Applicant Total
    6
    Review Days
    38

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    Basic Information

    Device Name
    GOAT ANTI-HUMAN C-REACTIVE PROTEIN
    K Number
    K791560
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Protos Laboratories
    Date Received
    August 17, 1979
    Decision Date
    September 24, 1979
    Product Code
    DCK
    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
    DCK C-Reactive Protein, Antigen, Antiserum, And Control

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