BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    IND URINARY TRACT INFECTION (UTI) TEST STRIPS

    K Number: K103037 · Decision Apr 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    551

    Basic Information

    Device Name
    IND URINARY TRACT INFECTION (UTI) TEST STRIPS
    K Number
    K103037
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1510
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    IND DIAGNOSTIC, INC.
    Date Received
    October 14, 2010
    Decision Date
    April 17, 2012
    Product Code
    NGJ
    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
    NGJ Test, Nitrite, Urinary, Non-Quantitative, Over The Counter