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

    BLEEDING TIME DEVICE DISPOSABLE

    K Number: K830645 · Decision Mar 17, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    149
    Review Days
    16

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    Basic Information

    Device Name
    BLEEDING TIME DEVICE DISPOSABLE
    K Number
    K830645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    March 1, 1983
    Decision Date
    March 17, 1983
    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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