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

    SAMPLOK

    K Number: K000777 · Decision Apr 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    33

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    Basic Information

    Device Name
    SAMPLOK
    K Number
    K000777
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Itl Corporation Pty, Ltd.
    Date Received
    March 9, 2000
    Decision Date
    April 11, 2000
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    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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    Other Clearances by Itl Corporation Pty, Ltd.

    K Number Device Name
    K153472 Quiver Laparoscopic Extendable
    K021941 SAMPLOK LUER KIT
    K021017 LEESPEC DISPOSABLE VAGINAL SPECULUM
    K991404 PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)