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

    POLIOVIRUS 2 MONOCLONAL ANTIBODY

    K Number: K940034 · Decision Sep 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    19
    Review Days
    616

    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
    POLIOVIRUS 2 MONOCLONAL ANTIBODY
    K Number
    K940034
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3405
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Diagnostics
    Date Received
    January 4, 1994
    Decision Date
    September 12, 1995
    Product Code
    GOE
    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
    GOE Antisera, Fluorescent, Poliovirus 1-3

    Similar 510(k) Clearances

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

    ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES

    FDA 510(k)
    FDA Class 1 ·Microbiology

    POLIOVIRUS 3 MONOCLONAL ANTIBODY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ENTEROVIRUS 71 MONOCLONAL ANTIBODY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    POLIOVIRUS BLEND MONOCLONAL ANTIBODIES

    FDA 510(k)
    FDA Class 1 ·Microbiology

    POLIOVIRUS 1 MONOCLONAL ANTIBODY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ENTEROVIRUS 70 MONCLONAL ANTIBODY

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

    Other Clearances by Light Diagnostics

    K Number Device Name
    K991880 LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
    K990141 LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
    K972975 LIGHT DIAGNOSTICS RABIES DFA REAGENT
    K974302 LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
    K951821 CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
    K951799 VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
    K940017 POLIOVIRUS 3 MONOCLONAL ANTIBODY
    K940026 POLIOVIRUS BLEND MONOCLONAL ANTIBODIES
    K936254 COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
    K936252 COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY
    Search all 19 clearances from Light Diagnostics →