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

    LABILE REMOVING HEMOLYZING REAGENT

    K Number: K830804 · Decision May 4, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    111
    Review Days
    51

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    Basic Information

    Device Name
    LABILE REMOVING HEMOLYZING REAGENT
    K Number
    K830804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7440
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Corning Medical & Scientific
    Date Received
    March 14, 1983
    Decision Date
    May 4, 1983
    Product Code
    JBD
    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
    JBD System, Analysis, Electrophoretic Hemoglobin

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