BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    cobas Cdiff nucleic acid test for use on the cobas Liat System

    K Number: K212427 · Decision Oct 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    16
    Applicant Total
    51
    Review Days
    77

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    Basic Information

    Device Name
    cobas Cdiff nucleic acid test for use on the cobas Liat System
    K Number
    K212427
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3130
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    August 4, 2021
    Decision Date
    October 20, 2021
    Product Code
    OZN
    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
    OZN C. Difficile Toxin Gene Amplification Assay

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