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

    FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

    K Number: K240351 · Decision Mar 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    22
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
    K Number
    K240351
    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., LLC
    Date Received
    February 5, 2024
    Decision Date
    March 6, 2024
    Product Code
    NGL
    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
    NGL Test, Opiates, Over The Counter

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    Other Clearances by Assure Tech., LLC

    K Number Device Name
    K260754 Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
    K252259 AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
    K250117 FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
    K243996 AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
    K243573 FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream