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

    NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET

    K Number: K900009 · Decision Mar 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    58
    Review Days
    86

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    Basic Information

    Device Name
    NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
    K Number
    K900009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Diag, A Div. of Erbamont, Inc.
    Date Received
    January 2, 1990
    Decision Date
    March 29, 1990
    Product Code
    KLS
    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
    KLS Enzyme Immunoassay, Theophylline

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