BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM

    K Number: K861773 · Decision Jul 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    61

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    Basic Information

    Device Name
    ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM
    K Number
    K861773
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5800
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Zygotek Systems, Inc.
    Date Received
    May 7, 1986
    Decision Date
    July 7, 1986
    Product Code
    DGB
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DGB Seminal Fluid, Antigen, Antiserum, Control