BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Simplexa GBS Direct, Simplexa GBS Positive Control Pack

    K Number: K182467 · Decision Nov 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    17
    Applicant Total
    14
    Review Days
    58

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    Basic Information

    Device Name
    Simplexa GBS Direct, Simplexa GBS Positive Control Pack
    K Number
    K182467
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diasorin Molecular, LLC
    Date Received
    September 10, 2018
    Decision Date
    November 7, 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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    Other Clearances by Diasorin Molecular, LLC

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    K212147 Simplexa COVID-19 Direct
    K201505 Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
    K192376 Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
    K190219 Simplexa VZV Direct, Simplexa VZV Positive Control Pack
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