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

    IMMUNODOT MONO-M TEST

    K Number: K974244 · Decision Sep 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    55
    Applicant Total
    10
    Review Days
    314

    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
    IMMUNODOT MONO-M TEST
    K Number
    K974244
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genbio
    Date Received
    November 12, 1997
    Decision Date
    September 22, 1998
    Product Code
    LSE
    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
    LSE Epstein-Barr Virus, Other

    Similar 510(k) Clearances

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

    ADVIA Centaur EBV-VCA IgM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SERAQUEST EBV EA-D IGG TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

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

    Other Clearances by Genbio

    K Number Device Name
    K010301 IMMUNOWELL EA (D) IGG TEST
    K974226 IMMUNODOT MONO-G TEST
    K973940 IMMUNOWELL EBV VCA IGG TEST
    K973939 IMMUNOWELL VCA IGM TEST
    K973941 IMMUNOWELL EBNA IGG TEST
    K963054 IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
    K963055 IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
    K953682 IMMUNO DOT BORRELIA DOT BLOT G TEST
    K953683 MMUNO DOT BORRELIA DOT BLOT M TEST