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

    STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER

    K Number: K902028 · Decision Jun 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    14
    Applicant Total
    7
    Review Days
    47

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    Basic Information

    Device Name
    STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER
    K Number
    K902028
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Norfolk Scientific, Inc.
    Date Received
    May 4, 1990
    Decision Date
    June 20, 1990
    Product Code
    JPI
    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
    JPI Device, Hematocrit Measuring

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