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

    UBIT-IR300 INFRARED SPECTROMETRY SYSTEM

    K Number: K013371 · Decision Dec 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    257
    Applicant Total
    6
    Review Days
    71

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    Basic Information

    Device Name
    UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
    K Number
    K013371
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2300
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Otsuka Pharmaceutical Co., Ltd.
    Date Received
    October 11, 2001
    Decision Date
    December 21, 2001
    Product Code
    JJQ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

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