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

    Q.I.C. BLEEDING TIME DEVICE

    K Number: K871318 · Decision Jun 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    280
    Review Days
    68

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    Basic Information

    Device Name
    Q.I.C. BLEEDING TIME DEVICE
    K Number
    K871318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Helena Laboratories
    Date Received
    April 3, 1987
    Decision Date
    June 10, 1987
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JCA), ordered by most recent decision date.

    SIMPLATE PEDIATRIC

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    SURGICUTT - BLEEDING TIME DEVICE

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    BLEEDING TIME DEVICE DISPOSABLE

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    AUTOLET

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    SIMPLATE

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