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

    MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup

    K Number: K162395 · Decision Jun 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    2
    Review Days
    280

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    Basic Information

    Device Name
    MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
    K Number
    K162395
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mp Biomedicals, LLC
    Date Received
    August 26, 2016
    Decision Date
    June 2, 2017
    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 Mp Biomedicals, LLC

    K Number Device Name
    K051958 MP RAPIDOXY TEST STRIP, MODEL 07RD-7073