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

    PHEM-CHEK

    K Number: K960648 · Decision May 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    PHEM-CHEK
    K Number
    K960648
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1550
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Femtek, Inc.
    Date Received
    February 14, 1996
    Decision Date
    May 13, 1996
    Product Code
    LNW
    Advisory Committee
    Clinical Chemistry
    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
    LNW Paper, Obstetric Ph

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