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

    Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test

    K Number: K260754 · Decision Jun 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    13
    Applicant Total
    6
    Review Days
    88

    Basic Information

    Device Name
    Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
    K Number
    K260754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3984
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Assure Tech., LLC
    Date Received
    March 9, 2026
    Decision Date
    June 5, 2026
    Product Code
    QYT
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QYT Over-The-Counter Covid-19 Antigen Test

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