BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    QMS(TM) - THEOPHYLLINE

    K Number: K885263 · Decision Mar 28, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    13
    Applicant Total
    28
    Review Days
    95

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    Basic Information

    Device Name
    QMS(TM) - THEOPHYLLINE
    K Number
    K885263
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Seradyn, Inc.
    Date Received
    December 23, 1988
    Decision Date
    March 28, 1989
    Product Code
    JQX
    Advisory Committee
    Clinical Chemistry
    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
    JQX Nephelometer, For Clinical Use

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