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

    PROLACTIN IRMA

    K Number: K842478 · Decision Sep 14, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    79
    Applicant Total
    5
    Review Days
    81

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    Basic Information

    Device Name
    PROLACTIN IRMA
    K Number
    K842478
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1625
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Euro-Diagnostics BV
    Date Received
    June 25, 1984
    Decision Date
    September 14, 1984
    Product Code
    CFT
    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
    CFT Radioimmunoassay, Prolactin (Lactogen)

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    Other Clearances by Euro-Diagnostics BV

    K Number Device Name
    K851332 BLHI LUTEINIZING HORMONE
    K851148 TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE
    K850053 BACI 6 -ADRENOCORTICOTROOP HORMONE
    K843930 IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I