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

    IREX REAL TIME PHASED ARRAY SYSTEM

    K Number: K791317 · Decision Sep 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    10
    Review Days
    67

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    Basic Information

    Device Name
    IREX REAL TIME PHASED ARRAY SYSTEM
    K Number
    K791317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Irex Corp.
    Date Received
    July 12, 1979
    Decision Date
    September 17, 1979
    Product Code
    CDP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CDP Radioimmunoassay, Total Triiodothyronine

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