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

    WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST

    K Number: K112395 · Decision Sep 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    20
    Applicant Total
    43
    Review Days
    21

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
    K Number
    K112395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3910
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Received
    August 19, 2011
    Decision Date
    September 9, 2011
    Product Code
    LFG
    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
    LFG Radioimmunoassay, Tricyclic Antidepressant Drugs

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LFG), ordered by most recent decision date.

    Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UCP MULTIPLE DRUG SCREEN TEST CUPS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VERDICT -II TCA, VERDICT-II MTD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    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. →