BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hemoglobin A1c Controls - LN 02K9610

    Reg #: 3005333358 · FEI: 3005333358 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ABBOTT LABORATORIES
    Registration Number
    3005333358
    FEI Number
    3005333358
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Conway Park, 675 North Field Drive
    City
    Lake Forest
    State
    IL
    ZIP
    60045
    Country
    US

    Regulatory Submissions

    510(k) Number
    K033674

    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
    Control, Hemoglobin GGM
    Assay, Glycosylated Hemoglobin LCP
    Calibrator For Hemoglobin And Hematocrit Measurement KRZ

    Proprietary Names

    Hemoglobin A1c Controls - LN 02K9610 Hemoglobin A1c Calibrators - LN 02K9602 Hemoglobin A1c - LN 02K9620

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198