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

    CRIT-LINE HEMATOCRIT ALERT

    K Number: K950942 · Decision Mar 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    14
    Applicant Total
    8
    Review Days
    27

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    Basic Information

    Device Name
    CRIT-LINE HEMATOCRIT ALERT
    K Number
    K950942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    In-Line Diagnostics Corp.
    Date Received
    February 15, 1995
    Decision Date
    March 14, 1995
    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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