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

    EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME

    K Number: K890859 · Decision Apr 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    50
    Applicant Total
    5
    Review Days
    59

    Basic Information

    Device Name
    EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME
    K Number
    K890859
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    ELITE DIAGNOSTIC LTD.
    Date Received
    February 21, 1989
    Decision Date
    April 21, 1989
    Product Code
    GFO
    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
    GFO Activated Partial Thromboplastin

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    Other Clearances by ELITE DIAGNOSTIC LTD.

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