BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ALINITY HQ ANALYZER (09P68-01)

    Reg #: 2919069 · FEI: 2919069 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ABBOTT LABORATORIES
    Registration Number
    2919069
    FEI Number
    2919069
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4551 Great America Pkwy
    City
    SANTA CLARA
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243283

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Counter, Differential Cell GKZ
    Slide Stainer, Automated KPA

    Proprietary Names

    ALINITY HQ ANALYZER (09P68-01) ALINITY HS SLIDE MAKER STAINER MODULE (09P69-01)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility