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

    ONTRAK TESTCARD 9

    K Number: K050321 · Decision Apr 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    5
    Review Days
    68

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    Basic Information

    Device Name
    ONTRAK TESTCARD 9
    K Number
    K050321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Varian, Inc.
    Date Received
    February 9, 2005
    Decision Date
    April 18, 2005
    Product Code
    DIO
    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
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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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
    K033902 ONTRAK TESTCUP II AND ONSITE CUPKIT
    K033659 VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK