BEUDAMED
    FDA Registration Active 🇺🇸 United States

    476836 Creatine Kinase Reagent (CK 2 x 400)

    Reg #: 2050012 · FEI: 2050012 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    2050012
    FEI Number
    2050012
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    250 S Kraemer Blvd
    City
    BREA
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K952427

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US

    Products

    Device Name Product Code
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA

    Proprietary Names

    476836 Creatine Kinase Reagent (CK 2 x 400) 442665 Aspartate Aminotransferase Reagent (AST 2 x 200) 467845 Aspartate Aminotransferase Reagent (AST- 2 x 300) 476831 Aspartate Aminotransferase Reagent (AST 2 x 400) 442635 Creatine Kinase Reagent (CK 2 x 200) 467849 Aspartate Aminotransferase Reagent (AST- 2 x 100) 467830 Creatine Kinase Reagent (N-Acetyl-L-cysteine) (CK- 2 x 200)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility