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

    MANUAL BLOOD CELL COUNTING DEVICE

    K Number: K841026 · Decision Apr 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    321
    Review Days
    23

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    Basic Information

    Device Name
    MANUAL BLOOD CELL COUNTING DEVICE
    K Number
    K841026
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.6160
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Laboratory CO
    Date Received
    March 12, 1984
    Decision Date
    April 4, 1984
    Product Code
    GKM
    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
    GKM Hand-Tally, Differential

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