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

    ON TRAK TESTCARD

    K Number: K051235 · Decision Jun 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    5
    Review Days
    26

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    Basic Information

    Device Name
    ON TRAK TESTCARD
    K Number
    K051235
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Varian, Inc.
    Date Received
    May 13, 2005
    Decision Date
    June 8, 2005
    Product Code
    DKZ
    Advisory Committee
    Clinical Toxicology
    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
    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
    K050321 ONTRAK TESTCARD 9
    K033902 ONTRAK TESTCUP II AND ONSITE CUPKIT
    K033659 VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK