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

    PEFAKIT APC-R FACTOR V LEIDEN

    K Number: K042762 · Decision Dec 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    PEFAKIT APC-R FACTOR V LEIDEN
    K Number
    K042762
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentapharm , Ltd.
    Date Received
    October 5, 2004
    Decision Date
    December 22, 2004
    Product Code
    GGW
    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
    GGW Test, Time, Partial Thromboplastin

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    Other Clearances by Pentapharm , Ltd.

    K Number Device Name
    K042760 PEFAKIT APC-R FACTOR V LEIDEN CONTROLS