BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard

    K Number: K142800 · Decision Dec 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    10
    Review Days
    73

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    Basic Information

    Device Name
    Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
    K Number
    K142800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Co-Innovation Biotech Co., Ltd.
    Date Received
    September 29, 2014
    Decision Date
    December 11, 2014
    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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