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

    DILU-MATIC 140

    K Number: K842446 · Decision Sep 6, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    13
    Applicant Total
    28
    Review Days
    77

    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
    DILU-MATIC 140
    K Number
    K842446
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.5240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Abbott Diagnostics
    Date Received
    June 21, 1984
    Decision Date
    September 6, 1984
    Product Code
    GKH
    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
    GKH Apparatus, Automated Blood Cell Diluting

    Similar 510(k) Clearances

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

    CELLTRACKS AUTOPREP SYSTEM MODEL:9541

    FDA 510(k)
    FDA Class 1 ·Hematology

    IMMUNICON CELLTRACKS AUTOPREP SYSTEM

    FDA 510(k)
    FDA Class 1 ·Hematology

    CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

    FDA 510(k)
    FDA Class 1 ·Hematology

    COULTER CELLPREP

    FDA 510(k)
    FDA Class 1 ·Hematology

    COULTER MULTI Q PREP

    FDA 510(k)
    FDA Class 1 ·Hematology

    COULTER MULTI-Q-PREP

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

    Other Clearances by Abbott Diagnostics

    K Number Device Name
    K964185 IMX CA 125
    K972182 ABBOTT STREP A CONTROLS
    K961439 ABBOTT CELL-DYN 4000 SYSTEM
    K890491 CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
    K881242 CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
    K881130 CELL-DYN ISOTONIC DILUENT
    K873348 CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
    K873347 CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
    K873408 MODEL 690 SPECTROPHOTOMETER
    K872761 CELL-DYN 610 HEMATOLOGY ANALYZER
    Search all 28 clearances from Abbott Diagnostics →