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

    KVM HEMOGLOBIN LYSING REAGENT

    K Number: K883991 · Decision Oct 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    28
    Applicant Total
    5
    Review Days
    22

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    Basic Information

    Device Name
    KVM HEMOGLOBIN LYSING REAGENT
    K Number
    K883991
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8540
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Kvm Technologies, Inc.
    Date Received
    September 20, 1988
    Decision Date
    October 12, 1988
    Product Code
    GGK
    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
    GGK Products, Red-Cell Lysing Products

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