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510(k) Data Aggregation

    K Number
    K081522
    Device Name
    BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
    Manufacturer
    BIO NUCLEAR DIAGNOSTICS, INC.
    Date Cleared
    2008-12-05

    (189 days)

    Product Code
    HHT
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO NUCLEAR DIAGNOSTICS, INC.

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

    The (Endo)cervical Sampler is intended for the collection of endocervical cells for PAP smear analysis. This device is not intended for use in pregnant women.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for an '(Endo)cervical Sampler'. It does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

    The letter confirms that the FDA has reviewed the submission and determined the device to be substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, marketing authorization, and general controls, rather than performance data or study details.

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

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