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

    QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2

    K Number: K993631 · Decision Dec 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    5
    Review Days
    43

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    Basic Information

    Device Name
    QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
    K Number
    K993631
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Seracare Technology
    Date Received
    October 27, 1999
    Decision Date
    December 9, 1999
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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