BEUDAMED
    FDA Registration Active 🇳🇴 Norway

    Alere Afinion HbA1c

    Reg #: 9613069 · FEI: 3003045237 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Abbott Diagnostics Technologies AS
    Registration Number
    9613069
    FEI Number
    3003045237
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kjelsaasveien 161
    City
    OSLO
    Country
    NO

    Regulatory Submissions

    510(k) Number
    K151809

    Owner / Operator

    Firm Name
    Abbott
    Operator Number
    9006731
    Address
    100 Abbott Park Road, Dept. RX51/J55/MS 6134
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Assay, Glycosylated Hemoglobin LCP
    Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica JQT

    Proprietary Names

    Alere Afinion HbA1c Alere Afinion AS100 Analyzer

    Establishment Types

    Manufacture Medical Device