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: K210385 · Decision Sep 9, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    15
    Applicant Total
    28
    Review Days
    212

    Basic Information

    Device Name
    cobas Cdiff nucleic acid test for use on the cobas Liat System
    K Number
    K210385
    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
    February 9, 2021
    Decision Date
    September 9, 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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