BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    iChemVELOCITY Automated Urine Chemistry System (800-7167)

    Reg #: 9680746 · FEI: 1000206808 · Expires 2025
    View on FDA
    Products
    12
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    Beckman Coulter Ireland Inc
    Registration Number
    9680746
    FEI Number
    1000206808
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LISMEEHAN
    City
    O CALLAGHANS MILLS Clare
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K101852

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US

    Products

    Device Name Product Code
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Test, Urine Leukocyte LJX
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Blood, Occult, Colorimetric, In Urine JIO
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Refractometer For Clinical Use JRE
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Automated Urinalysis System KQO
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN

    Proprietary Names

    iChemVELOCITY Automated Urine Chemistry System (800-7167) Back-Integrated iChemVELOCITY (800-7720) Stand-Alone iChemVELOCITY (800-7719) iChemVELOCITY Computerless (800-3530) iChemVELOCITY Automated Urine Chemistry System w load/unload (800-7166) UA Win10 Kit (C52900) iChemVELOCITY Urine Chemistry Strips (800-7212)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)