BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MASS TRAK KIT QUALITY CONTROL

    Reg #: 1218959 · FEI: 1218959 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    WATERS CORPORATION
    Registration Number
    1218959
    FEI Number
    1218959
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    34 MAPLE ST
    City
    MILFORD
    State
    MA
    ZIP
    01757
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063868

    Owner / Operator

    Firm Name
    WATERS CORPORATION
    Operator Number
    1218959
    Address
    34 Maple Street
    City
    Milford
    State
    MA
    Postal Code
    01757
    Country
    US
    Correspondent
    Raajdeep Venkatesan

    Products

    Device Name Product Code
    Enzyme Immunoassay, Tracrolimus MLM
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    MASS TRAK KIT QUALITY CONTROL MASS TRAK KIT CALIBRATOR MASS TRAK IMMUNOSUPPRESSANTS KIT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198