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

    Quidel Triage® TOX Drug Screen, 94600

    K Number: K200363 · Decision Mar 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    2
    Review Days
    26

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    Basic Information

    Device Name
    Quidel Triage® TOX Drug Screen, 94600
    K Number
    K200363
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quidel Cardiovascular, Inc.
    Date Received
    February 14, 2020
    Decision Date
    March 11, 2020
    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 Quidel Cardiovascular, Inc.

    K Number Device Name
    K182719 Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro