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510(k) Data Aggregation

    K Number
    K071737
    Device Name
    GENERAL SEMEN ANALYSIS KIT
    Manufacturer
    DYN-BIOSHAF (2006) LTD.
    Date Cleared
    2007-10-25

    (121 days)

    Product Code
    POVGKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYN-BIOSHAF (2006) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GSA kit is for the evaluation of human semen and provides a set of reagents to evaluate semen quality by measuring five parameters, recommended by the World Health Organization (WHO), that are used to determine whether infertility is caused by abnormalities of one or more of them. The parameters include: Sperm Count, sperm motility, sperm viability, white blood cell (WBC) count, and Sperm head morphology (the subject of this 510(k) submission.
    Device Description
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