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

    ORTHO AUTOMATED CELL COUNTER

    K Number: K801545 · Decision Sep 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    6
    Review Days
    64

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    Basic Information

    Device Name
    ORTHO AUTOMATED CELL COUNTER
    K Number
    K801545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Instruments
    Date Received
    July 7, 1980
    Decision Date
    September 9, 1980
    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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