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

    GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688

    K Number: K033038 · Decision Dec 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    10
    Applicant Total
    270
    Review Days
    91

    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
    GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
    K Number
    K033038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    September 29, 2003
    Decision Date
    December 29, 2003
    Product Code
    NIG
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

    Similar 510(k) Clearances

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

    VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack

    FDA 510(k)
    FDA Class 2 ·Immunology

    Lumipulse G CA19-9-N

    FDA 510(k)
    FDA Class 2 ·Immunology

    Lumpipulse G CA19-9-N

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604

    FDA 510(k)
    FDA Class 2 ·Immunology

    VITROS CA 19-9

    FDA 510(k)
    FDA Class 2 ·Immunology

    ARCHITECT CA 19-9XR ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology
    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. →