BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)

    K Number: K110889 · Decision Jun 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    2
    Review Days
    82

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    Basic Information

    Device Name
    IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
    K Number
    K110889
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ind Diagnostics, Inc.
    Date Received
    March 30, 2011
    Decision Date
    June 20, 2011
    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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    Other Clearances by Ind Diagnostics, Inc.

    K Number Device Name
    K113506 IND ONE STEP OCCULT BLOOD (FOB) TEST