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

    cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

    K Number: K202215 · Decision Sep 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    51
    Review Days
    27

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    Basic Information

    Device Name
    cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
    K Number
    K202215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3183
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    August 6, 2020
    Decision Date
    September 2, 2020
    Product Code
    QMI
    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
    QMI Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

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