BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Hemoglobin A1c Calibrators (LN 4P52-01)

    Reg #: 3002809144 · FEI: 3002809144 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ABBOTT GmbH
    Registration Number
    3002809144
    FEI Number
    3002809144
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Max-Planck-Ring 2
    City
    Wiesbaden Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K140654

    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

    US Agent

    Business Name
    ABBOTT LABORATORIES
    Contact Name
    Sara Qadri
    Address
    675 N Field Dr, Dept C2D8 Bldg CP01 Floor-3
    City
    Lake Forest
    State
    IL
    ZIP
    60045
    Country
    US
    Email
    [email protected]
    Phone
    224 6680142

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Assay, Glycosylated Hemoglobin LCP
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Hemoglobin A1c Test System PDJ

    Proprietary Names

    Hemoglobin A1c Calibrators (LN 4P52-01) Hemoglobin A1c Controls (LN 4P52-11) Hemoglobin A1c (LN 4P52-20) Alinity c Hemoglobin A1c Reagent Kit (LN 08P4320)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device