BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    RAMP RSV ASSAY

    K Number: K091235 · Decision Jul 24, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    31
    Applicant Total
    7
    Review Days
    88

    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
    RAMP RSV ASSAY
    K Number
    K091235
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Response Biomedical Corp.
    Date Received
    April 27, 2009
    Decision Date
    July 24, 2009
    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

    Nano-Check™ RSV 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
    View all

    Other Clearances by Response Biomedical Corp.

    K Number Device Name
    K093116 MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
    K063662 RAMP NT-PROBNP ASSAY
    K071591 RAMP INFLUENZA A/B ASSAY
    K033747 RAMP CK-MB ASSAY
    K033745 RAMP TROPONIN I ASSAY
    K012040 RAMP MYOGLOBIN ASSAY