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

    A1 SYSTEME 8201/2

    K Number: K841803 · Decision Feb 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    5
    Review Days
    300

    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
    A1 SYSTEME 8201/2
    K Number
    K841803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Med USA
    Date Received
    May 1, 1984
    Decision Date
    February 25, 1985
    Product Code
    GKL
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GKL Counter, Cell, Automated (Particle Counter)

    Similar 510(k) Clearances

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

    Glocyte Automated Cell Counter System

    FDA 510(k)
    FDA Class 2 ·Hematology

    IQ 200 URINE ANALIZER BODY FLUIDS MODULE

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOCUE WBC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    IQ 200 URINE ANALYZER BODY FLUIDS MODULE

    FDA 510(k)
    FDA Class 2 ·Hematology

    SYSMEX POCH-100I

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

    Other Clearances by Med USA

    K Number Device Name
    K896766 TD-28 DISPOSABLE ELECTRODE
    K862047 COAGULATOR (8 CHANNEL)
    K852492 COAGULATOR
    K850711 INHALATION THERAPY NEBULIZER DEVICE