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

    ANALYST THEOPHYLLINE CALIBRATOR

    K Number: K884170 · Decision Nov 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    13
    Review Days
    56

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    Basic Information

    Device Name
    ANALYST THEOPHYLLINE CALIBRATOR
    K Number
    K884170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    The DU Pont Co.
    Date Received
    September 21, 1988
    Decision Date
    November 16, 1988
    Product Code
    DLJ
    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
    DLJ Calibrators, Drug Specific

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