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

    ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY

    K Number: K031506 · Decision Jun 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    105
    Applicant Total
    270
    Review Days
    19

    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
    ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
    K Number
    K031506
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    May 14, 2003
    Decision Date
    June 2, 2003
    Product Code
    LGD
    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
    LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

    Similar 510(k) Clearances

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

    Access Toxo IgG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Access Toxo IgM II

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Alinity i Toxo IgM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ARCHITECT Toxo IgG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ADVIA Centaur Toxoplasma M (Toxo M)

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

    Other Clearances by Beckman Coulter, Inc.

    K Number Device Name
    K252169 Access BNP II
    K254059 Access anti-HBc IgM
    K253687 Access anti-HBc Total
    K251995 Access anti-HAV IgM
    K250588 Access Rubella IgG
    K252580 iQ200 Series
    K243846 Access anti-HAV
    K243804 MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
    K250036 MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
    K243483 Access hsTnI
    Search all 270 clearances from Beckman Coulter, Inc. →