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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: CEO FDA class 1

    Phosphomolybdate (Colorimetric), Inorganic Phosphorus

    Clinical Chemistry

    View full classification →

    The Phosphomolybdate Colorimetric Inorganic Phosphorus Test is a clinical chemistry device that measures inorganic phosphorus levels in blood or urine using the phosphomolybdate colorimetric method, in which phosphate reacts with ammonium molybdate to form a colored complex, used in the evaluation of phosphate metabolism, renal function, and parathyroid disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CEO, regulated under 21 CFR 862.1580, within the Clinical Chemistry medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
    S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
    SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
    ATAC PAK PHOSPHORUS REAGENT
    PICCOLO PHOSPHORUS TEST SYSTEM
    WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
    PHOSPHORUS REAGENT
    RAICHEM PHOSPORUS REAGENT
    INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
    ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347
    HICHEM PHOSPHORUS REAGENT KIT
    CARESIDE ANALYZER
    PHOS
    PHOS
    PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30
    RANDOX INORGANIC PHOSPHOROUS
    SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT
    INORGANIC PHOSPHORUS REAGENT
    OLYMPUS INORGANIC PHOSPHORUS REAGENT
    PHOSPHATE QVET
    PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416
    PHOSPHORUS TEST (PHOS)
    EMDS PHOSPHOROUS (PHOS) TEST
    OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT
    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS)
    IL TEST PHOSPHORUS
    OLYMPUS INORGANIC PHOSPHORUS REAGENT
    TWO PART INORGANIC PHOSPHORUS TEST
    SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000
    OLYMPUS INORGANIC PHOSPHORUS REAGENT
    INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET
    ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14
    SYNERMED PHOSPHORUS REAGENT KIT
    PHOSPHORUS (INORGANIC) TEST SYSTEM
    OLYMPUS INORGANIC PHOSPHORUS
    PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463
    OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)
    CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)
    AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500
    COULTER PHOSPHORUS REAGENT
    PHOSPHORUS
    HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196
    IQ/QCA PHOSPHORUS
    BIOTROL INORGANIC PHOSPHORUS
    PHOSPHORUS TEST (PHOS) ITEM #65666
    ROCHE REAGENT FOR INORGANIC PHOSPHORUS
    PHOSPHORUS (INORGANIC)
    INORGANIC PHOSPHORUS REAGENT SET
    KODAK EKTACHEM DT SLIDES (PHOS)
    INORGANIC PHOSPHORUS

    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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