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

    R&D HGB/GLC WHOLE BLOOD CONTROL

    K Number: K993321 · Decision Nov 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    14
    Applicant Total
    79
    Review Days
    39

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    Basic Information

    Device Name
    R&D HGB/GLC WHOLE BLOOD CONTROL
    K Number
    K993321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R&D Systems, Inc.
    Date Received
    October 4, 1999
    Decision Date
    November 12, 1999
    Product Code
    GGM
    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
    GGM Control, Hemoglobin

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