BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇧🇪 Belgium

    Panther Fusion GBS Assay

    K Number: K181156 · Decision Jul 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    Panther Fusion GBS Assay
    K Number
    K181156
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagenode
    Date Received
    May 1, 2018
    Decision Date
    July 27, 2018
    Product Code
    NJR
    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
    NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

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