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

    VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126

    K Number: K033879 · Decision Feb 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    23
    Review Days
    74

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    Basic Information

    Device Name
    VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
    K Number
    K033879
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maine Standards Co.
    Date Received
    December 15, 2003
    Decision Date
    February 27, 2004
    Product Code
    DKB
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DKB Calibrators, Drug Mixture

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