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

    RAPI - STAPH

    K Number: K852997 · Decision Aug 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    7
    Review Days
    35

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    Basic Information

    Device Name
    RAPI - STAPH
    K Number
    K852997
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Medical Technology, Inc.
    Date Received
    July 15, 1985
    Decision Date
    August 19, 1985
    Product Code
    JWX
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JWX Kit, Screening, Staphylococcus Aureus

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