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

    Nano-Check™ RSV Test

    K Number: K240280 · Decision Jul 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    31
    Applicant Total
    6
    Review Days
    180

    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
    Nano-Check™ RSV Test
    K Number
    K240280
    Device Class
    FDA class 1
    Clearance Type
    Dual Track
    Regulation Number
    866.3480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nano-Ditech Corporation
    Date Received
    February 1, 2024
    Decision Date
    July 30, 2024
    Product Code
    GQG
    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
    GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

    Similar 510(k) Clearances

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

    Clungene RSV Antigen Rapid Test

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Sofia RSV FIA on Sofia 2 analyzer

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SOFIA(R) RSV FIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV

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

    Other Clearances by Nano-Ditech Corporation

    K Number Device Name
    K252283 Nano-Check Influenza A+B Test
    K243561 Nano-Check Influenza+COVID-19 Dual Test
    K231187 Nano-Check™ COVID-19 Antigen Test
    K102131 NANO-CHECK AMI CTNI CARDIAC MARKER TEST
    K102441 NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN