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510(k) Data Aggregation

    K Number
    K041240
    Device Name
    SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
    Manufacturer
    FERTILITY SOLUTIONS, INC.
    Date Cleared
    2004-06-02

    (22 days)

    Product Code
    NRF
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERTILITY SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For In Vitro Diagnostic Use The AQC™ Sperm Count and AQC™ Post-vasectomy Quality Controls are intended for monitoring sperm counts performed either manually using commercially available counting chambers or using computer assisted semen analysis (CASA) instruments. The AQC™ Sperm Count and AQC™ Postvasectomy Quality Controls are intended for use as Quality Control materials having known sperm concentrations. Daily monitoring of the control values establishes intra-laboratory parameters for accuracy and precision of the cell counting methods. These products are also available for external laboratory quality control and proficiency testing and as such are sold under the proprietary trade names, AQC™ Spenn Count and AQC™ Post-Yasectomy Proficiency Challe Challenges.
    Device Description
    AOC™ Sperm Count and AQC™ Post-Vasectomy Quality Controls are supplied in two levels, 0.3mL per vial. AQC™ Sperm Count and AQC™ Post-Vasectomy Proficiency Challenges are supplied in two levels, 0.15mL per vial. Each control is a ready-to-use liquid requiring no reconstitution or dilution. The liquid is prepared in a solution fortified to target levels with purified chemicals and stabilized human sperm cells and semen. Preservatives, including formalin, have been added to inhibit microbial growth and inactivate potential infectious agents.
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