BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ALBUMIN REAGENT SET

    K Number: K843831 · Decision Oct 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    16
    Review Days
    10

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    Basic Information

    Device Name
    ALBUMIN REAGENT SET
    K Number
    K843831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Livonia Diagnostics, Inc.
    Date Received
    October 1, 1984
    Decision Date
    October 11, 1984
    Product Code
    CIX
    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
    CIX Bromcresol Green Dye-Binding, Albumin

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    Other Clearances by Livonia Diagnostics, Inc.

    K Number Device Name
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    K844237 ALKALINE PHOSPHATASE REAGENT SET
    K844156 UREA NITROGEN REAGENT SET
    K844182 INORGANIC PHOSPHORUS REAGENT SET
    K843894 HDL PRECIPATATING REAGENT SET
    K843893 MAGNESIUM REAGENT SET
    K844024 CREATININE REAGENT SET
    K843895 TOTAL CALCIUM REAGENT SET
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