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

    VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK

    K Number: K033659 · Decision Jan 6, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    5
    Review Days
    46

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    Basic Information

    Device Name
    VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
    K Number
    K033659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Varian, Inc.
    Date Received
    November 21, 2003
    Decision Date
    January 6, 2004
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Varian, Inc.

    K Number Device Name
    K060896 MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
    K051235 ON TRAK TESTCARD
    K050321 ONTRAK TESTCARD 9
    K033902 ONTRAK TESTCUP II AND ONSITE CUPKIT