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

    QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS

    K Number: DEN130005 · Decision Aug 8, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    30
    Review Days
    72

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    Basic Information

    Device Name
    QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
    K Number
    DEN130005
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    862.3652
    Medical Specialty
    Clinical Toxicology
    Decision
    Unknown
    Applicant
    Centers for Disease Control and Prevention
    Date Received
    May 28, 2013
    Decision Date
    August 8, 2013
    Product Code
    PDY
    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
    PDY Organophosphate Test System

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