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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: GKZ FDA class 2

    Counter, Differential Cell

    Hematology

    View full classification →

    The Differential Cell Counter is a laboratory instrument used in hematology to identify and quantify the different types of white blood cells present in a blood sample, supporting the diagnosis of infections, blood disorders, and other conditions. It is classified as FDA Class 2 (moderate risk), meaning it is subject to general controls and requires a 510(k) premarket notification before it can be marketed. The product code is GKZ and it falls under regulation 21 CFR 864.5220 within the Hematology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    XR-Series (XR-10, XR-20) Automated Hematology Analyzers
    Athelas Home
    Tru Hematology Test
    Sysmex XR-Series (XR-10) Automated Hematology Analyzer
    Sysmex XR-Series (XR-20) Automated Hematology Analyzer
    Alinity h-series System
    Cito CBC System
    UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
    Yumizen H2500
    HemoScreen Hematology Analyzer
    Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
    QScout Lab; QScout RLD
    HemoScreen Hematology Analyzer
    Alinity h-series System
    Sysmex XW-100 Automated Hematology Analyzer
    Sight OLO
    Athelas Home
    Unicel DxH 800 Coulter Cellular Analysis System
    Sight OLO
    Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
    CELL-DYN Emerald 22 AL System
    DxH 520 Hematology Instrument
    Sysmex XN-L Automated Hematology Analyzer
    Athelas One
    HemoScreen Hematology Analyzer
    cobas m 511 integrated hematology analyzer
    XW-100 Automated Hematology Analyzer for CLIA Waived Use
    ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
    ADVIA 2120i, ADVIA 2120
    Dextramer CMV Kit
    Sysmex XN-L Automated Hematology Analyzer
    UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
    BC-5390 Auto Hematology Analyzer
    PENTRA XLR
    XW-100 Automated Hematology Analyzer, XW QC CHECK
    BC-3600 Auto Hematology Analyzer
    ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)
    SYSMEX XN SERIES
    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
    SYSMEX XN-SERIES
    ABACUS 3CP
    ABACUS 5
    CELL-DYN EMERALD 22 SYSTEM
    ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
    BD FACS SAMPLE PREP ASSISTANT III (SPA III)
    DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771
    ADVIA 2120/2120I BODY FLUIDS
    BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C
    SYSMEX MODEL XT-4000I

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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