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

    ACTICHROME ATIII KIT

    K Number: K893608 · Decision Jun 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    39
    Review Days
    44

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    Basic Information

    Device Name
    ACTICHROME ATIII KIT
    K Number
    K893608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    American Diagnostic Corp.
    Date Received
    May 10, 1989
    Decision Date
    June 23, 1989
    Product Code
    JBQ
    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
    JBQ Antithrombin Iii Quantitation

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