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

    ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT

    K Number: K821554 · Decision Jun 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    5
    Review Days
    31

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    Basic Information

    Device Name
    ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT
    K Number
    K821554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Amf Biological and Diagnostics Co.
    Date Received
    May 25, 1982
    Decision Date
    June 25, 1982
    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 Amf Biological and Diagnostics Co.

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