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

    THEOPHYLLINE TEST KIT REF. #A874799

    K Number: K880291 · Decision Mar 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    12
    Review Days
    59

    Basic Information

    Device Name
    THEOPHYLLINE TEST KIT REF. #A874799
    K Number
    K880291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    PHOTEC DIAGNOSTICS, INC.
    Date Received
    January 25, 1988
    Decision Date
    March 24, 1988
    Product Code
    LCA
    Advisory Committee
    Clinical Toxicology
    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
    LCA Radioimmunoassay, Theophylline

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