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

    PROLACTIN IRMA IMMUNOMAG

    K Number: K914107 · Decision Sep 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    79
    Applicant Total
    16
    Review Days
    17

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    Basic Information

    Device Name
    PROLACTIN IRMA IMMUNOMAG
    K Number
    K914107
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1625
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pantex, Div. Bio-Analysis, Inc.
    Date Received
    September 13, 1991
    Decision Date
    September 30, 1991
    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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