BEUDAMED
    FDA Registration Active 🇺🇸 United States

    K-ASSAY(R) D-Dimer Calibrator

    Reg #: 2084025 · FEI: 2084025 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    KAMIYA BIOMEDICAL COMPANY LLC
    Registration Number
    2084025
    FEI Number
    2084025
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12779 Gateway Dr S
    City
    Tukwila
    State
    WA
    ZIP
    98168
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030687

    Owner / Operator

    Firm Name
    KAMIYA BIOMEDICAL COMPANY LLC
    Operator Number
    9001370
    Address
    12779 GATEWAY DRIVE S
    City
    Tukwila
    State
    WA
    Postal Code
    98168
    Country
    US
    Correspondent
    COLIN GETTY

    Products

    Device Name Product Code
    Fibrin Split Products GHH
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP

    Proprietary Names

    K-ASSAY(R) D-Dimer Calibrator K-ASSAY(R) D-Dimer

    Establishment Types

    Manufacture Medical Device