BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Atellica CH 930 Analyzer (Refurbished)

    Reg #: 2247117 · FEI: 1000122204 · Expires 2025
    View on FDA
    Products
    7
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Inc.
    Registration Number
    2247117
    FEI Number
    1000122204
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    62 FLANDERS-BARTLEY RD.
    City
    FLANDERS
    State
    NJ
    ZIP
    07836
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151767

    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
    Electrode, Ion-Specific, Chloride CGZ
    Bromcresol Purple Dye-Binding, Albumin CJW
    Calibrator, Secondary JIT
    Calibrator, Multi-Analyte Mixture JIX
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Potassium CEM
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    Atellica CH 930 Analyzer (Refurbished) Atellica CH Check Reagent (CHK) Atellica CH Reagent Probe Cleaner 4 (RPC4) Atellica CH IMT Dilution Check (IMT Dilution Check) Atellica CH IMT Diluent (IMT Diluent) Atellica CH Albumin BCP Calibrator (AlbP CAL) Atellica CH IMT Standard B + Salt Bridge (IMT Standard B + Salt Bridge) Atellica CH Conditioner Atellica CH EMPTY Atellica CH Reagent Probe Cleaner 1 (RPC1) Atellica CH Cleaner Atellica CH Diluent Atellica CH IMT Standard A (IMT Standard A) Atellica CH Wash Atellica CH Lamp Coolant (LC) Atellica CH Reagent Probe Cleaner 2 (RPC2) Atellica Direct Load Atellica CH Water Bath Additive (WBA) Atellica CH 930 Analyzer Atellica CH HA1c_E High Volume Conversion Kit Atellica CH EMPTY1 Atellica CH EMPTY2 Atellica CH Lid Keying Feature Atellica CH HA1c_E High Volume Bottles Atellica CH HA1c_E High Volume Lables

    Establishment Types

    Manufacture Medical Device