BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Clinitek Atlas Pro 12 Reagent Pak

    Reg #: 3009448641 · FEI: 3009448641 · Expires 2025
    View on FDA
    Products
    12
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics, Inc.
    Registration Number
    3009448641
    FEI Number
    3009448641
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    430 S Beiger St
    City
    Mishawaka
    State
    IN
    ZIP
    46544
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021428

    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

    Products

    Device Name Product Code
    Test, Urine Leukocyte LJX
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Blood, Occult, Enzymatic Method, In Urine JIP
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Refractometer For Clinical Use JRE
    Automated Urinalysis System KQO
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Enzymatic Method, Creatinine JFY

    Proprietary Names

    Clinitek Atlas Pro 12 Reagent Pak

    Establishment Types

    Manufacture Medical Device