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510(k) Data Aggregation

    K Number
    K981243
    Device Name
    BIOSTRIDE FREE T4 EIA TEST KIT
    Date Cleared
    1998-06-29

    (84 days)

    Product Code
    Regulation Number
    862.1695
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOSTRIDE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Enzyme immunoassay is used for the quantitative estimation of non-protein bound thyroxine(Free T4) in human serum. This is an in vitro diagnostic device used to assist in the assessment of thyroid function.
    Device Description
    The Biostride Free T4 EIA Test Kit is an in vitro enzyme immunoassay for the quantitative estimation of freeT4, thyroxine, in human serum. This Free T4 test is a colorimetric microtiter plate enzyme immunoassay (EIA).
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