BEUDAMED
    FDA Registration Active 🇺🇸 United States

    K-ASSAY(R) Lp(a) 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
    K021660

    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
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    Calibrator, Primary JIS

    Proprietary Names

    K-ASSAY(R) Lp(a) Calibrator K-ASSAY(R) Lp(a)

    Establishment Types

    Manufacture Medical Device