BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    CLEARVIEW C. DIFF A

    K Number: K955067 · Decision Sep 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    9
    Applicant Total
    73
    Review Days
    312

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    Basic Information

    Device Name
    CLEARVIEW C. DIFF A
    K Number
    K955067
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Unipath , Ltd.
    Date Received
    November 6, 1995
    Decision Date
    September 13, 1996
    Product Code
    MCB
    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
    MCB Antigen, C. Difficile

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