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

    OREIA-T4

    K Number: K780308 · Decision Apr 12, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    41
    Review Days
    48

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    Basic Information

    Device Name
    OREIA-T4
    K Number
    K780308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Organon, Inc.
    Date Received
    February 23, 1978
    Decision Date
    April 12, 1978
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

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    Other Clearances by Organon, Inc.

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    K831339 NEO-PREGNOSTICON DUOCLON TUBE TEST
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