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

    PICSI SPERM SELECTION DEVICE

    K Number: K052457 · Decision Apr 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    218

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    Basic Information

    Device Name
    PICSI SPERM SELECTION DEVICE
    K Number
    K052457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biocoat, Inc.
    Date Received
    September 7, 2005
    Decision Date
    April 13, 2006
    Product Code
    MQK
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQK Labware, Assisted Reproduction

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    Other Clearances by Biocoat, Inc.

    K Number Device Name
    K032874 HBA SPERM-HYALURONAN BINDING ASSAY