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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: KIS FDA class 1

    Sera, Animal And Human

    Hematology

    View full classification →

    Animal and Human Sera are biological reagents derived from the serum component of animal or human blood, used in laboratory cell culture systems to supply growth factors, nutrients, and proteins that support cell viability and proliferation in in vitro diagnostic and research applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIS, regulated under 21 CFR 864.2800, within the Hematology medical specialty.

    510(k) Clearances

    45 matches
    K Number
    Device Name
    ANIMAL AND HUMAN SERA
    BOVINE CALF SERUM SUPPLEMENTED #A-2159
    BOVINE CALF SERUM CATALOG #A-2119
    SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT
    MLC NORMAL SERUM
    FETAL BOVINE SERUM
    ADULT BOVINE SERUM
    DEFINED FETAL BOVINE SERUM #A-1111
    DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151
    DEFINED CALF BOVINE SERUM #A-2111
    CHARACTERIZED FETAL BOVINE SERUM #A-1115
    DEFINED EQUINE SERUM #A-3311
    6/40 FETAL BOVINE SERUM #A-1110
    MOUSE SERUM - STERILE FILTERED
    MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE
    HUMAN SERUM - STERILE FILTERED
    RHESUS MONKEY SERUM - STERILE FILTERED
    LAMB SERUM - STERILE FILTERED
    HUMAN AB SERUM - STERILE FILTERED
    BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE
    CHICKEN SERUM - STERILE FILTERED
    HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED
    GOAT SERUM (29-391-54)
    GAMMA-FREE HORSE SERUM
    FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB
    FETAL BOVINE SERUM, F4884 STERILE GROWT
    CLEX
    DONOR HORSE SERUM - STERILE
    NEWBORN CALF SERUM - STERILE
    GUINEA PIG SERUM - STERILE
    NATAL CALF (BOVINE) SERUM - STERILE
    FETAL BOVINE SERUM - STERILE
    RABBIT SERUM - STERILE
    CALF (BOVINE) SERUM - STERILE
    DONOR CALF (BOVINE-SERUM) - STERILE
    ZETA-SERA D
    GOAT SERUM-STERILE
    FETAL CALF SERUM
    NEWBORN BOVINE SERUM
    BOVINE CALF SERUM
    ANIMAL SERUM PRODUCTS
    NORMLCERA
    FETAL BOVINE SERUM
    FETAL BOVINE SERUM
    GUINEA PIG WHOLE SERUM

    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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