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

    HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS

    K Number: K854236 · Decision Oct 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    32
    Applicant Total
    9
    Review Days
    354

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    Basic Information

    Device Name
    HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS
    K Number
    K854236
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Nms Pharmaceuticals, Inc.
    Date Received
    October 21, 1985
    Decision Date
    October 10, 1986
    Product Code
    IAF
    Advisory Committee
    Hematology
    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
    IAF Wright'S Stain

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