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

    PROSTATE-63 CANCER DIAGNOSTIC TEST

    K Number: K050063 · Decision Feb 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    29

    Basic Information

    Device Name
    PROSTATE-63 CANCER DIAGNOSTIC TEST
    K Number
    K050063
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ASYMMETRX
    Date Received
    January 11, 2005
    Decision Date
    February 9, 2005
    Product Code
    NTR
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NTR Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells