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

    REDI-TEST OPIATES

    K Number: K991883 · Decision Sep 15, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    10
    Review Days
    105

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    Basic Information

    Device Name
    REDI-TEST OPIATES
    K Number
    K991883
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advantage Diagnostics Corp.
    Date Received
    June 2, 1999
    Decision Date
    September 15, 1999
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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    Other Clearances by Advantage Diagnostics Corp.

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    K001567 ADVANTAGE THC TEST
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    K903416 CANNULA, SURGICAL
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