BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Catachem

    Reg #: 2434178 · FEI: 2434178 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CATACHEM, INC.
    Registration Number
    2434178
    FEI Number
    2434178
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    353 Christian St Ste 2
    City
    Oxford
    State
    CT
    ZIP
    06478
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062503

    Owner / Operator

    Firm Name
    CATACHEM, INC.
    Operator Number
    2434178
    Address
    353 CHRISTIAN STREET, SUITE #2
    City
    Oxford
    State
    CT
    Postal Code
    06478
    Country
    US
    Correspondent
    David M Templeton

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Radioimmunoassay, Cholyglycine, Bile Acids KWW
    Calibrator, Primary JIS

    Proprietary Names

    Catachem DiscretPak™

    Establishment Types

    Manufacture Medical Device