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

    NORDICLAB FERRITIN IRMA TEST

    K Number: K801989 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    NORDICLAB FERRITIN IRMA TEST
    K Number
    K801989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Nordiclab Intl.
    Date Received
    August 19, 1980
    Decision Date
    September 16, 1980
    Product Code
    DBF
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DBF Ferritin, Antigen, Antiserum, Control

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    Other Clearances by Nordiclab Intl.

    K Number Device Name
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    K800922 NORDICLAB PROGESTERONE RIA TEST
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    K800920 NORDICLAB ESTRADIOL RIA TEST
    K792189 NORDICLAB TOTAL ESTRIOL RIA TEST
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