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    K Number
    K090760
    Device Name
    THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2009-09-03

    (164 days)

    Product Code
    JZO
    Regulation Number
    866.5870
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TheraTest EL-Anti-TPO™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroid peroxidase (TPO) in human serum. The TheraTest EL-Anti-TPO™ assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings.

    The TheraTest EL-Anti-Thyroglobulin™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroglobulin in human serum. The TheraTest EL-Anti-ThyroglobulinTM assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510k clearance letter for a medical device. There is no information in the document to extract an answer for the user's request. There is no mention of acceptance criteria or study details within the given text.

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