BEUDAMED
    FDA Registration Active 🇨🇳 China

    Mission U120 Touch Urine Analyzer

    Reg #: 9615507 · FEI: 3002829675 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    ACON BIOTECH (HANGZHOU) CO., LTD.
    Registration Number
    9615507
    FEI Number
    3002829675
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 210 Zhenzhong Road, West Lake District
    City
    HANGZHOU Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K070929

    Owner / Operator

    Firm Name
    ACON Laboratories Inc.
    Operator Number
    9033096
    Address
    5850 Oberlin Drive, #340
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Catherine Shi

    US Agent

    Business Name
    ACON LABORATORIES INC.
    Contact Name
    Catherine Shi
    Address
    5850 Oberlin Drive, #340
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 8758068

    Products

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

    Proprietary Names

    Mission U120 Touch Urine Analyzer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)