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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: JPK FDA class 2

    Mixture, Hematology Quality Control

    Hematology

    View full classification →

    The Mixture, Hematology Quality Control is a hematology laboratory product consisting of prepared control materials used to verify the accuracy, precision, and performance of hematology analyzers and related instruments as part of laboratory quality assurance programs. This device is FDA Class 2, indicating moderate risk; it does not require a 510(k) under its current submission type but is subject to general and special controls. It carries product code JPK and is regulated under 21 CFR 864.8625, within the Hematology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    XN-L CHECK
    XN CHECK BF
    XN CHECK
    BC-5D Hematology Control
    XN CHECK
    XN CHECK BF
    R&D 5D RETIC HEMATOLOGY CONTROL
    XN CHECK BF
    XN CHECK
    R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
    COULTER LIN-X LINEARITY CONTROL, MODEL A81196
    COULTER 4C-EX 300 CELL CONTROL
    LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
    R & D SYSTEMS XERET HEMATOLOGY CONTROL
    R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
    UA-CELLULAR FOR IQ
    COULTER BODY FLUID CONTROL
    COULTER 6C CELL CONTROL, MODELS 628027 & A59925
    COULTER LIN-X LINEARITY CONTROL
    HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
    CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
    HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
    CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
    RETIC-CHEX LINEARITY FOR BC
    E-CHECK (XE)
    R&D CBC-3D + CRP HEMATOLOGY CONTROL
    R&D LH-NRBC HEMATOLOGY CONTROL
    COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
    COULTER 5C CELL CONTROL
    CELL-CHEX AUTO
    IQ BODY FLUIDS CONTROL
    R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
    ABX ERYTROL
    LIQUICHEK RETICULOCYTE CONTROL (A)
    RETIC-CHEX FOR CELL-DYN
    METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
    R&D CBC-XE HEMATOLOGY CONTROL
    LIQUICHEK HEMATOLOGY CONTROL (A)
    CDS 3-PD HEMATOLOGY CONTROLS
    ADVIA TESTPOINT CSF CONTROL
    MODIFICATION TO PARA 5X
    R & D BODY FLUID CONTROL
    R&D RET-LINE KIT
    IMMUNO-TROL LOW CELLS
    PARA 5X
    R & D 4K RETIC
    ADVIA RETIC PLUS
    SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
    CBC-SF
    4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190

    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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