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

    UPLINK TEST SYSTEM

    K Number: K020371 · Decision Apr 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    30
    Review Days
    58

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    Basic Information

    Device Name
    UPLINK TEST SYSTEM
    K Number
    K020371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OraSure Technologies, Inc.
    Date Received
    February 4, 2002
    Decision Date
    April 3, 2002
    Product Code
    DJG
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DJG Enzyme Immunoassay, Opiates

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