BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ADVIA Centaur HER-2/neu (H2n)

    Reg #: 2432235 · FEI: 2432235 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Inc.
    Registration Number
    2432235
    FEI Number
    2432235
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    511 Benedict Ave
    City
    Tarrytown
    State
    NY
    ZIP
    10591
    Country
    US

    Regulatory Submissions

    510(k) Number
    K024017

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US
    Correspondent
    Mary Seeger

    Products

    Device Name Product Code
    System, Test, Her-2/Neu, Monitoring NCW

    Proprietary Names

    ADVIA Centaur HER-2/neu (H2n) ADVIA Centaur HER-2/neu Calibrator (H2n Cal) Atellica IM HER-2/neu 1,2 Quality Control Material (H2n QC) Atellica IM HER-2/neu Calibrator (H2n Cal) ADVIA Centaur HER-2/neu 1,2 Quality Control Material (H2n QC) Atellica IM HER-2/neu (H2n)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility