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

    OSOM C. DIFFICILE TOXIN A/B TEST

    K Number: K102242 · Decision Dec 21, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    41
    Applicant Total
    6
    Review Days
    134

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    Basic Information

    Device Name
    OSOM C. DIFFICILE TOXIN A/B TEST
    K Number
    K102242
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genzyme Corporation
    Date Received
    August 9, 2010
    Decision Date
    December 21, 2010
    Product Code
    LLH
    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
    LLH Reagents, Clostridium Difficile Toxin

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