BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Accuwell Total Galactose Neonatal Screening Kit

    Reg #: 3050015 · FEI: 3050015 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ASTORIA-PACIFIC,INC.
    Registration Number
    3050015
    FEI Number
    3050015
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15130 S.E. 82ND DR.
    City
    Clackamas
    State
    OR
    ZIP
    97015
    Country
    US

    Regulatory Submissions

    510(k) Number
    K991498

    Owner / Operator

    Firm Name
    ASTORIA-PACIFIC, INC.
    Operator Number
    3050015
    Address
    15130 S.E. 82ND DR.
    City
    Clackamas
    State
    OR
    Postal Code
    97015
    Country
    US
    Correspondent
    Jason C Adams

    Products

    Device Name Product Code
    Enzymatic Methods, Galactose JIA

    Proprietary Names

    Accuwell Total Galactose Neonatal Screening Kit PRIME Total Galactose Neonatal Screening Kit BioDominium Diagnostics Total Galactose Neonatal Screening Kit SPOTCHECK Total Galactose Neonatal Screening Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device