BEUDAMED
    FDA Registration Active 🇺🇸 United States

    hemochroma PLUS Control

    Reg #: 2244821 · FEI: 2244821 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    IMMUNOSTICS, INC.
    Registration Number
    2244821
    FEI Number
    2244821
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    38 Industrial Way E Ste 1
    City
    Eatontown
    State
    NJ
    ZIP
    07724
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163465

    Owner / Operator

    Firm Name
    IMMUNOSTICS, INC.
    Operator Number
    2244821
    Address
    38 INDUSTRIAL WAY EAST, SUITE 1, --
    City
    Eatontown
    State
    NJ
    Postal Code
    07724
    Country
    US
    Correspondent
    Young Mi Kim

    Products

    Device Name Product Code
    System, Hemoglobin, Automated GKR
    Control, Hemoglobin GGM

    Proprietary Names

    hemochroma PLUS Control hemochroma PLUS Analyzer Promo Kit hemochroma PLUS Optical System Check hemochroma PLUS Microcuvettes hemochroma PLUS Analyzer

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device