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510(k) Data Aggregation

    K Number
    K113506
    Device Name
    IND ONE STEP OCCULT BLOOD (FOB) TEST
    Manufacturer
    IND DIAGNOSTICS INC.
    Date Cleared
    2012-12-19

    (387 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K110889
    Device Name
    IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
    Manufacturer
    IND DIAGNOSTICS INC.
    Date Cleared
    2011-06-20

    (82 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IND One Step hCG Urine Pregnancy Tests Device is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use.
    Device Description
    Not Found
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