BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ISIweb

    Reg #: 3037000637 · FEI: 3037000637 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INSTRUMENTATION LABORATORY CO. - Devens
    Registration Number
    3037000637
    FEI Number
    3037000637
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    11 Grant Road
    City
    Devens
    State
    MA
    ZIP
    01434
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090563

    Owner / Operator

    Firm Name
    Instrumentation Laboratory Co.
    Operator Number
    1217183
    Address
    180 Hartwell Road, --
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Carol - Marble

    Products

    Device Name Product Code
    Calculator/Data Processing Module, For Clinical Use JQP
    Calibrator, Primary JIS
    Plasma, Coagulation Control GGN

    Proprietary Names

    ISIweb HemosIL INR Validate HemosIL ISI Calibrate

    Establishment Types

    Repack or Relabel Medical Device