BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    UNISCAN -DOA SYSTEM

    K Number: K080347 · Decision Oct 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    244

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    Basic Information

    Device Name
    UNISCAN -DOA SYSTEM
    K Number
    K080347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taiwan Unison Biotech, Inc.
    Date Received
    February 8, 2008
    Decision Date
    October 9, 2008
    Product Code
    DJC
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DJC Thin Layer Chromatography, Methamphetamine

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