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510(k) Data Aggregation

    K Number
    K983599
    Device Name
    SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
    Manufacturer
    ANDWIN SCIENTIFIC
    Date Cleared
    1998-12-11

    (58 days)

    Product Code
    HHT
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SAFETEX Chlamydia trachomatis Direct Specimen Collection Kit is utilized in situations where an in vitro diagnosis is warranted in obtaining cytology specimens for Chlamydial diagnostic testing.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding the K983599 submission for the "Safetex Chlamydia Trachomatis Specimen Collection Kit." It states that the device has been found substantially equivalent to predicate devices, but it does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based solely on the provided text.

    The document primarily focuses on regulatory approval and general controls provisions of the Medical Device Amendments. It does not include the detailed technical or clinical study data that would be necessary to answer your questions.

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