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

    cobas HSV 1 and 2 Test

    K Number: K150617 · Decision Jun 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    11
    Applicant Total
    51
    Review Days
    83

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    Basic Information

    Device Name
    cobas HSV 1 and 2 Test
    K Number
    K150617
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    March 10, 2015
    Decision Date
    June 1, 2015
    Product Code
    OQO
    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
    OQO Herpes Simplex Virus Nucleic Acid Amplification Assay

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