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

    CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY

    K Number: K001943 · Decision Aug 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    58

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    Basic Information

    Device Name
    CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
    K Number
    K001943
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1360
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sangui Biotech, Inc.
    Date Received
    June 26, 2000
    Decision Date
    August 23, 2000
    Product Code
    NAO
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NAO Test, Carbohydrate Deficient Transferrin

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