BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ABBOTT LABORATORIES

    Reg #: 2919069 · FEI: 2919069 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ABBOTT LABORATORIES
    Registration Number
    2919069
    FEI Number
    2919069
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    647 Almanor Ave.
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061667

    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

    Proprietary Names

    CELL-DYN Ruby System (LN 08H67-01, 08H67-03) CELL-DYN Immuno PLT (CD61) Reagent (LN 03H05-01) CELL-DYN Sapphire System (LN 08H00-01, 08H00-03) CELL-DYN Immuno T-Cell (CD3/4/8) Reagents (LN 07H22-01)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility