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

    CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION

    K Number: K905521 · Decision Dec 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    107
    Review Days
    19

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    Basic Information

    Device Name
    CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
    K Number
    K905521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Microgenics Corp.
    Date Received
    December 7, 1990
    Decision Date
    December 26, 1990
    Product Code
    LER
    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
    LER Fluorescent Immunoassay, Theophylline

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