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

    ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)

    K Number: K761289 · Decision Mar 28, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    632
    Review Days
    98

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    Basic Information

    Device Name
    ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)
    K Number
    K761289
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    December 20, 1976
    Decision Date
    March 28, 1977
    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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