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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: JJJ FDA class 1

    Counter (Beta, Gamma) For Clinical Use

    Clinical Chemistry

    View full classification →

    This device is a beta and gamma radiation counter used in clinical laboratory settings to quantify radioactive isotopes in patient specimens or reagents, supporting radioimmunoassay and other radiometric testing procedures. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket notification. The product code is JJJ, regulated under 21 CFR 862.2320, and assigned to the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
    CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER
    ABBOTT VERTEX ANALYZER
    GENESYS 6000 GAMMA COUNTER
    MATRIX(TM)-96
    SOURCERER
    SOURCERER
    SAMPLE IDENTIFICATION STATION MODEL 38010
    1205 BETAPLATE LIQUID SCINTILLATION COUNTER
    ISO-DATA 500 SERIES GAMMA COUNTER
    ISO-DATA 100 SERIES GAMMA COUNTER
    BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS
    TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER
    DENTOCULT CULTURE-PADDLE
    GENESYS GAMMA COUNTER
    1208 BETACORD AND 1208 BETCORD M
    MICROSTAT GAMMA COUNTER
    ND1200 RIA COUNTER
    CORNING 4000 MULTI-WELL GAMMA COUNTER
    KEMTEK 400 RIA GAMMA COUNTER
    KEMTEK 104 RIA GAMMA COUNTER
    KEMTEK 103 RIA GAMMA COUNTER
    GAMMA PHOTON GAMMA COUNTER
    KINETI COUNT 24 GAMMA COUNTER
    NML-5010/5020 MULTI-DETECTOR SYSTEM
    KEMTEK 102
    KINETI COUNT 48 IMMUNOASSAY SYSTEM
    CAP-RIA 16
    IMMU-COUNT 404
    PHILLIPS RADIATION MEASURING INSTRUMENT
    RIA STAT 16
    MICROMEDIC SYSTEMS ISOFLEX
    IMMU-COUNT
    LS 5800 SERIES LIQUID SCINTILLATION
    LIQUID SCINTILLATION SPECTROPHOTOMETER
    PACE-4-AUTOMATIC RIA GAMMA-COUTER
    NUCLEAR ENTERPRISES 1600/GAMMA COUNTER
    NUCLEAR ENTERPRISES 1612 MULTI-WELL
    ATOMLIGHT (LIQUID SCINTILLATION SOLUTION
    HYDRAGAMMA 16
    NML 5000 AUTO. GAMMA SCINT. COUNTER
    LIQUID SCINTILLATION COUNTER
    NUCLEAR SAMPLE READER
    IDI 200 GAMMA COUNTER
    SCINTILLATION, LIQUID, RACKBETA
    AUTO. WELL TYPE GAMMA COUNTERS
    GAMMA COUNTER
    WELL TYPE GAMMA COUNTER
    WELL TYPE GAMMA COUNTER
    COUNTER, RADIOASSAY, AUTO., MICROMEDIC

    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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