BEUDAMED
    Product Code: DKO FDA class 1 21 CFR 862.2230

    Adsorbents, Ion-Exchange

    Clinical Chemistry

    Ion-Exchange Adsorbents are packing materials used in ion-exchange chromatography columns to separate and purify analytes from biological specimens based on charge interactions, with applications in clinical chemistry and toxicology testing. This device is classified as FDA Class 1, indicating low risk, and is subject only to general controls without premarket notification requirements. It is regulated under 21 CFR 862.2230 within the Clinical Chemistry specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    DKO
    Device Class
    FDA class 1
    Regulation Number
    862.2230
    Medical Specialty
    Clinical Chemistry
    Review Panel
    TX
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K873932 THE EXTRACTOR(TM)

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.