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

    ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD

    K Number: K140215 · Decision Jun 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    10
    Review Days
    139

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    Basic Information

    Device Name
    ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
    K Number
    K140215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Co-Innovation Biotech Co., Ltd.
    Date Received
    January 28, 2014
    Decision Date
    June 16, 2014
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

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