BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)

    K Number: K131232 · Decision May 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    62
    Applicant Total
    43
    Review Days
    30

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    Basic Information

    Device Name
    WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
    K Number
    K131232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3620
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Received
    May 1, 2013
    Decision Date
    May 31, 2013
    Product Code
    DJR
    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
    DJR Enzyme Immunoassay, Methadone

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    Other Clearances by Guangzhou Wondfo Biotech Co., Ltd.

    K Number Device Name
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    K251289 WELLlife COVID-19 Antigen Test Rx
    K241317 Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
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    K202567 Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
    K182701 Wondfo T-Cup Multi-Drug Urine Test Cup
    K173229 Preview Digital Pregnancy Test
    K162333 Wondfo One Step Fecal Occult Blood (FOB) Test
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    Search all 43 clearances from Guangzhou Wondfo Biotech Co., Ltd. →