BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED

    K Number: K041240 · Decision Jun 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    22

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    Basic Information

    Device Name
    SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
    K Number
    K041240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fertility Solutions, Inc.
    Date Received
    May 11, 2004
    Decision Date
    June 2, 2004
    Product Code
    NRF
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NRF Material, Quality Control, Semen Analysis

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