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

    MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT

    K Number: K060896 · Decision Jun 9, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    30
    Applicant Total
    5
    Review Days
    67

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    Basic Information

    Device Name
    MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
    K Number
    K060896
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Varian, Inc.
    Date Received
    April 3, 2006
    Decision Date
    June 9, 2006
    Product Code
    DJC
    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
    DJC Thin Layer Chromatography, Methamphetamine

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    Other Clearances by Varian, Inc.

    K Number Device Name
    K051235 ON TRAK TESTCARD
    K050321 ONTRAK TESTCARD 9
    K033902 ONTRAK TESTCUP II AND ONSITE CUPKIT
    K033659 VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK