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

    APTT REAGENT

    K Number: K904341 · Decision Nov 8, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    51
    Applicant Total
    231
    Review Days
    49

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    Basic Information

    Device Name
    APTT REAGENT
    K Number
    K904341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Chemical Co.
    Date Received
    September 20, 1990
    Decision Date
    November 8, 1990
    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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