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

    VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody

    K Number: DEN170030 · Decision Oct 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    150

    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
    VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
    K Number
    DEN170030
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    864.1866
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Ventana Medical Systems
    Date Received
    May 30, 2017
    Decision Date
    October 27, 2017
    Product Code
    PZJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PZJ Lynch Syndrome Test System

    Similar 510(k) Clearances

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

    Idylla MSI Test

    FDA 510(k)
    FDA Class 2 ·Immunology

    BOND MMR Antibody Panel

    FDA 510(k)
    FDA Class 2 ·Immunology

    OncoMate MSI Dx Analysis System

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