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

    LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST

    K Number: K894279 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    142
    Applicant Total
    632
    Review Days
    53

    Basic Information

    Device Name
    LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
    K Number
    K894279
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Received
    June 23, 1989
    Decision Date
    August 15, 1989
    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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