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

    HBA SPERM-HYALURONAN BINDING ASSAY

    K Number: K032874 · Decision Nov 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    HBA SPERM-HYALURONAN BINDING ASSAY
    K Number
    K032874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biocoat, Inc.
    Date Received
    September 15, 2003
    Decision Date
    November 24, 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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