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

    ID NOW Influenza A & B 2

    K Number: K191534 · Decision Jul 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    78
    Applicant Total
    6
    Review Days
    31

    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
    ID NOW Influenza A & B 2
    K Number
    K191534
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Diagnostics Scarborough, Inc.
    Date Received
    June 10, 2019
    Decision Date
    July 11, 2019
    Product Code
    OCC
    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
    OCC Respiratory Virus Panel Nucleic Acid Assay System

    Similar 510(k) Clearances

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

    BioCode® Respiratory Pathogen Panel (RPP)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NxTAG® Respiratory Pathogen Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ID NOW Influenza A & B 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Panther Fusion AdV/hMPV/RV Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System

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

    Other Clearances by Abbott Diagnostics Scarborough, Inc.

    K Number Device Name
    K250273 BinaxNOW COVID-19 Ag Card
    K243518 BinaxNOW™ COVID-19 Antigen Self Test
    K232775 ID NOW Influenza A & B 2
    K221925 ID NOW COVID-19 2.0
    K220801 ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2