BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NOVEOS™ Specific IgE (sIgE) Assay Capture Reagent – M006, Alternaria alternata

    Reg #: 2016473 · FEI: 1000125787 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HYCOR BIOMEDICAL
    Registration Number
    2016473
    FEI Number
    1000125787
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7272 Chapman Ave
    City
    GARDEN GROVE
    State
    CA
    ZIP
    92841
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220162

    Owner / Operator

    Firm Name
    Hycor Biomedical
    Operator Number
    2016473
    Address
    7272 Chapman Avenue
    City
    Garden Grove
    State
    CA
    Postal Code
    92841
    Country
    US
    Correspondent
    Aashrey Kaul

    Products

    Device Name Product Code
    System, Test, Radioallergosorbent (Rast) Immunological DHB

    Proprietary Names

    NOVEOS™ Specific IgE (sIgE) Assay Capture Reagent – M006, Alternaria alternata

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device