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

    ACTIVATED PARTIAL THROMBOPLASTIN TIME

    K Number: K915463 · Decision Jan 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    164
    Review Days
    50

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    Basic Information

    Device Name
    ACTIVATED PARTIAL THROMBOPLASTIN TIME
    K Number
    K915463
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    December 4, 1991
    Decision Date
    January 23, 1992
    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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