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

    REFEREE BRAND CO-OXIMETER REAGENTS

    K Number: K830180 · Decision Apr 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    57
    Review Days
    80

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    Basic Information

    Device Name
    REFEREE BRAND CO-OXIMETER REAGENTS
    K Number
    K830180
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Analytical Products, Inc.
    Date Received
    January 18, 1983
    Decision Date
    April 8, 1983
    Product Code
    KHG
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KHG Whole Blood Hemoglobin Determination

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