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

    AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

    K Number: K180349 · Decision Apr 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    29
    Applicant Total
    7
    Review Days
    56

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    Basic Information

    Device Name
    AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
    K Number
    K180349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Assure Tech. (Hangzhou) Co, Ltd.
    Date Received
    February 8, 2018
    Decision Date
    April 5, 2018
    Product Code
    NFT
    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
    NFT Test, Amphetamine, Over The Counter

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