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

    SIMPLATE PEDIATRIC

    K Number: K911745 · Decision Aug 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    130
    Review Days
    113

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    Basic Information

    Device Name
    SIMPLATE PEDIATRIC
    K Number
    K911745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Organon Teknika Corp.
    Date Received
    April 18, 1991
    Decision Date
    August 9, 1991
    Product Code
    JCA
    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
    JCA Device, Bleeding Time

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