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

    AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

    K Number: K201630 · Decision Aug 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    7
    Review Days
    422

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    Basic Information

    Device Name
    AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
    K Number
    K201630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Assure Tech. (Hangzhou) Co, Ltd.
    Date Received
    June 16, 2020
    Decision Date
    August 12, 2021
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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