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

    WHOLE BLOOD PLATELET COUNTER -2510

    K Number: K760765 · Decision Dec 30, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    WHOLE BLOOD PLATELET COUNTER -2510
    K Number
    K760765
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Clay Adams, Div. Becton Dickinson & Co.
    Date Received
    October 4, 1976
    Decision Date
    December 30, 1976
    Product Code
    GKL
    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
    GKL Counter, Cell, Automated (Particle Counter)

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