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

    LANCER HEMOGLOBIN ANALYZER REAGENTS

    K Number: K831253 · Decision May 9, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    191
    Review Days
    21

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    Basic Information

    Device Name
    LANCER HEMOGLOBIN ANALYZER REAGENTS
    K Number
    K831253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6710
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Sherwood Medical Co.
    Date Received
    April 18, 1983
    Decision Date
    May 9, 1983
    Product Code
    KMG
    Advisory Committee
    General Hospital
    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
    KMG Purifier, Water, Ultraviolet, Medical

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