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

    NORDICLAB TESTOSTERONE RIA TEST

    K Number: K800921 · Decision May 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    8
    Review Days
    23

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    Basic Information

    Device Name
    NORDICLAB TESTOSTERONE RIA TEST
    K Number
    K800921
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nordiclab Intl.
    Date Received
    April 21, 1980
    Decision Date
    May 14, 1980
    Product Code
    CDZ
    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
    CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

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    Other Clearances by Nordiclab Intl.

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    K800920 NORDICLAB ESTRADIOL RIA TEST
    K792189 NORDICLAB TOTAL ESTRIOL RIA TEST
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