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

    MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700

    K Number: K983562 · Decision Nov 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700
    K Number
    K983562
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cdc Technologies, Inc.
    Date Received
    October 13, 1998
    Decision Date
    November 3, 1998
    Product Code
    GKZ
    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
    GKZ Counter, Differential Cell

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    Other Clearances by Cdc Technologies, Inc.

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