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

    LITHIUM HEPARINIZED BLOOD COLLECT-TUBE

    K Number: K831242 · Decision May 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    149
    Review Days
    31

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    Basic Information

    Device Name
    LITHIUM HEPARINIZED BLOOD COLLECT-TUBE
    K Number
    K831242
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    April 15, 1983
    Decision Date
    May 16, 1983
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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