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

    GENERAL SEMEN ANALYSIS (GSA) KIT

    K Number: K024337 · Decision Jul 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    188

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    Basic Information

    Device Name
    GENERAL SEMEN ANALYSIS (GSA) KIT
    K Number
    K024337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioshaf , Ltd.
    Date Received
    December 27, 2002
    Decision Date
    July 3, 2003
    Product Code
    POV
    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
    POV Semen Analysis Device

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