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

    FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

    K Number: K250117 · Decision Feb 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    6
    Review Days
    28

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    Basic Information

    Device Name
    FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
    K Number
    K250117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Assure Tech., LLC
    Date Received
    January 16, 2025
    Decision Date
    February 13, 2025
    Product Code
    LCX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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