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

    WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)

    K Number: K132630 · Decision Sep 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    30
    Applicant Total
    43
    Review Days
    36

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    Basic Information

    Device Name
    WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
    K Number
    K132630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Received
    August 22, 2013
    Decision Date
    September 27, 2013
    Product Code
    DJC
    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
    DJC Thin Layer Chromatography, Methamphetamine

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    Other Clearances by Guangzhou Wondfo Biotech Co., Ltd.

    K Number Device Name
    K260065 SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
    K252550 SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
    K251289 WELLlife COVID-19 Antigen Test Rx
    K241317 Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
    K241741 SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel
    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
    K161214 Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
    Search all 43 clearances from Guangzhou Wondfo Biotech Co., Ltd. →