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

    FluChip-8G Influenza A+B Assay

    K Number: K182513 · Decision Apr 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    222

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    FluChip-8G Influenza A+B Assay
    K Number
    K182513
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Indevr, Inc.
    Date Received
    September 12, 2018
    Decision Date
    April 22, 2019
    Product Code
    OZE
    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
    OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OZE), ordered by most recent decision date.

    CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Lyra Influenza A+B Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all