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

    QUICK VUE INFLUENZA

    K Number: K131599 · Decision Jul 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    37
    Review Days
    32

    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
    QUICK VUE INFLUENZA
    K Number
    K131599
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quidel Corporation
    Date Received
    June 3, 2013
    Decision Date
    July 5, 2013
    Product Code
    GNX
    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
    GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

    Similar 510(k) Clearances

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

    ALERE BINAXNOW INFLUENZA A & B CARD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SAS FLUALERT A & B, SAS INFLUENZA A TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    REMEL XPECT FLU A&B

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SOFIA INFLUENZA A+B FIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QUICKVUE INFLUENZA A+B

    FDA 510(k)
    FDA Class 1 ·Microbiology

    OSOM INFLUENZA A&B TEST MODEL 190

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Quidel Corporation

    K Number Device Name
    K231795 QuickVue COVID-19 Test
    K232286 Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
    K233688 Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
    K230349 Lyra RSV+hMPV Assay
    DEN220039 Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
    K230236 Lyra Influenza A+B Assay
    K211342 Sofia 2 Campylobacter FIA
    K173496 Sofia 2 Lyme FIA, Sofia Lyme Control Set
    K181029 Solana Bordetella Complete Assay
    K173691 Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
    Search all 37 clearances from Quidel Corporation →