BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Hp Detect™ Stool Antigen ELISA

    K Number: K232892 · Decision Dec 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    90
    Applicant Total
    10
    Review Days
    88

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    Basic Information

    Device Name
    Hp Detect™ Stool Antigen ELISA
    K Number
    K232892
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomerica, Inc.
    Date Received
    September 18, 2023
    Decision Date
    December 15, 2023
    Product Code
    LYR
    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
    LYR Helicobacter Pylori

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