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

    BLHI LUTEINIZING HORMONE

    K Number: K851332 · Decision Jul 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    142
    Applicant Total
    5
    Review Days
    96

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    Basic Information

    Device Name
    BLHI LUTEINIZING HORMONE
    K Number
    K851332
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Euro-Diagnostics BV
    Date Received
    April 4, 1985
    Decision Date
    July 9, 1985
    Product Code
    CEP
    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
    CEP Radioimmunoassay, Luteinizing Hormone

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    Other Clearances by Euro-Diagnostics BV

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