BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GloCyte Automated Cell Counter System

    Reg #: 1217058 · FEI: 1217058 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Advanced Instruments, LLC
    Registration Number
    1217058
    FEI Number
    1217058
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Technology Way
    City
    NORWOOD
    State
    MA
    ZIP
    02062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152776

    Owner / Operator

    Firm Name
    ADVANCED INSTRUMENTS, LLC
    Operator Number
    1217058
    Address
    2 TECHNOLOGY WAY, --
    City
    Norwood
    State
    MA
    Postal Code
    02062
    Country
    US
    Correspondent
    Lisa - Alexander

    Products

    Device Name Product Code
    Counter, Cell, Automated (Particle Counter) GKL
    Mixture, Hematology Quality Control JPK

    Proprietary Names

    GloCyte Automated Cell Counter System GloCyte Low and High Level Controls GloCyte Verification and Linearity Kit

    Establishment Types

    Manufacture Medical Device