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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO NUCLEAR DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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