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

    RAPIDEC UR

    K Number: K894805 · Decision Sep 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    43
    Applicant Total
    6
    Review Days
    60

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    Basic Information

    Device Name
    RAPIDEC UR
    K Number
    K894805
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Dms Products, Inc.
    Date Received
    July 28, 1989
    Decision Date
    September 26, 1989
    Product Code
    JXA
    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
    JXA Kit, Screening, Urine

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    Other Clearances by Dms Products, Inc.

    K Number Device Name
    K891004 RAPIDEC STAPH
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    K854733 API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)
    K854732 API 50 CHB (CULTURE MEDIA)