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

    QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST

    K Number: K112449 · Decision Sep 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    223
    Applicant Total
    11
    Review Days
    396

    Basic Information

    Device Name
    QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
    K Number
    K112449
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Received
    August 25, 2011
    Decision Date
    September 24, 2012
    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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