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

    ANTITHROMBIN III SCREEN KIT

    K Number: K812215 · Decision Sep 1, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    29
    Review Days
    27

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    Basic Information

    Device Name
    ANTITHROMBIN III SCREEN KIT
    K Number
    K812215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Pacific Hemostasis
    Date Received
    August 5, 1981
    Decision Date
    September 1, 1981
    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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