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

    QWIKCHECK-BEADS

    K Number: K041600 · Decision Jul 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    43

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    Basic Information

    Device Name
    QWIKCHECK-BEADS
    K Number
    K041600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Electronics Systems , Ltd.
    Date Received
    June 14, 2004
    Decision Date
    July 27, 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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