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

    CORDIA PAP

    K Number: K831105 · Decision May 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    44
    Applicant Total
    315
    Review Days
    41

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    Basic Information

    Device Name
    CORDIA PAP
    K Number
    K831105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Cordis Corp.
    Date Received
    April 5, 1983
    Decision Date
    May 16, 1983
    Product Code
    JFH
    Advisory Committee
    Clinical Chemistry
    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
    JFH Acid Phosphatase (Prostatic), Tartrate Inhibited

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